Medical connectors and methods of use

ABSTRACT

Some embodiments disclosed herein relate to a medical connector having a backflow resistance module configured to prevent fluid from being drawn into the connector when a backflow inducing event occurs. In some embodiments, the backflow resistance module can include a variable-volume chamber configured to change in volume in response to a backflow-inducing event and a check valve configured to resist backflow. In some embodiments, the medical connector can include a fluid diverter configured to direct fluid flowing through the medical connector into the variable volume chamber to prevent fluid stagnation therein. In some embodiments, the medical connector includes a body member, a base member, a seal member, a support member, and a valve member.

RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 13/857,019,filed on Apr. 4, 2013, which is a continuation of U.S. patentapplication Ser. No. 12/730,074, filed on Mar. 23, 2010, now U.S. Pat.No. 8,454,579, which claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 61/163,367, filed on Mar. 25, 2009,and entitled “Medical Connectors And Methods Of Use,” and U.S.Provisional Patent Application No. 61/251,232, filed on Oct. 13, 2009,and entitled “Medical Connectors And Methods Of Use,” the entirecontents of all of which are hereby incorporated by reference herein andmade part of this specification for all that they disclose.

BACKGROUND OF THE DISCLOSURE

1. Field of the Disclosure

Embodiments of the invention relate generally to medical connectorsthrough which fluids flow, and in particular, to self-sealing medicalconnectors.

2. Background of the Disclosure

Closeable medical connectors or valves are useful in the administrationof fluids in hospital and medical settings. Such closeable medicalconnectors can be repeatedly connectable with a range of other medicalimplements and can be self-sealing when disconnected from other medicalimplements.

SUMMARY OF SOME EMBODIMENTS

Some embodiments disclosed herein relate to a closed, patient accesssystem which can automatically reseal after administering fluid,medicaments, or other suitable substances (hereinafter, collectivelyreferred to as “fluid”) using a medical implement that connects orcommunicates with the system. A two-way valve can be employed, utilizinga reusable seal that may be repeatedly opened. The valve can facilitatethe transfer of fluid, particularly liquid, while maintaining sterility.After use, the valve can be swabbed in a conventional manner with asuitable substance to maintain sterility.

Some embodiments disclosed herein relate to a medical connector having abackflow resistance module configured to prevent fluid from being drawninto the connector when a backflow inducing event occurs (e.g., asyringe rebound, a syringe disconnection, etc.). In some embodiments,the backflow resistance module can include a variable volume chamberconfigured to change in volume in response to a backflow-inducing eventand a check valve configured to resist backflow. In some embodiments,the medical connector can include a fluid diverter configured to directfluid flowing through the medical connector into the variable volumechamber to prevent fluid stagnation therein. In some embodiments, themedical connector includes a body member, a base member, a seal member,a support member, and a valve member.

BRIEF DESCRIPTION OF THE DRAWINGS

Certain embodiments of the inventions will now be discussed in detailwith reference to the following figures. These figures are provided forillustrative purposes only, and the inventions are not limited to thesubject matter illustrated in the figures.

FIG. 1 is a schematic illustration of certain components of someembodiments of medical connectors.

FIG. 2A is a proximal perspective view of an embodiment of a valve orneedleless connector.

FIG. 2B is a distal perspective view of the embodiment of the connectorshown in FIG. 2A.

FIG. 3 is a proximal exploded view of the embodiment of the connectorshown in FIG. 2A.

FIG. 4 is a distal exploded view of the embodiment of the connectorshown in FIG. 2A.

FIG. 4A is an exploded section view of the embodiment of the connectorshown in FIG. 2A, taken through the axial centerline of the connector.

FIG. 5 is a perspective view of an embodiment of a seal member of theembodiment of the connector shown in FIG. 2A.

FIG. 6 is another perspective view of the embodiment of the seal membershown in FIG. 5.

FIG. 7 is a proximal perspective view of an embodiment of a supportmember of the embodiment of the connector shown in FIG. 2A.

FIG. 8 is a distal perspective view of the embodiment of the supportmember shown in FIG. 7.

FIG. 9 is a section view of the embodiment of a support member shown inFIG. 7, taken through the axial centerline of the support member.

FIG. 10 is a proximal perspective view of an embodiment of a regulatorof the embodiment of the connector shown in FIG. 2A.

FIG. 11 is a distal perspective view of the embodiment of the regulatorshown in FIG. 10.

FIG. 12 is a section view of the embodiment of the regulator shown inFIG. 10, taken through the axial centerline of the regulator.

FIG. 13 is a section view of the embodiment of the connector shown inFIG. 2A, showing the seal member in a first or closed position beforethe seal member has been contacted and opened by a medical implement,such as the illustrated example of a syringe.

FIG. 14 is a section view of the embodiment of the connector shown inFIG. 2A, showing the seal member in a second or open position after theseal member has been contacted and opened by the syringe.

FIG. 15 is a schematic illustration showing the embodiment of theconnector of FIG. 2A being used to inject fluids into the blood streamof a patient's arm.

FIG. 16 is a section view of the embodiment of the connector shown inFIG. 2A, showing the seal member in an open position and the plunger ofthe syringe advanced to the bottom surface of the syringe.

FIG. 17 is a section view of the embodiment of the connector shown inFIG. 2A, showing the seal member in an open position and the syringeafter the plunger of the syringe has rebounded away from the bottomsurface of the syringe.

FIG. 17A is a section view of the embodiment of the connector shown inFIG. 2A, showing the seal member in the first position after the syringehas been removed from the connector.

FIG. 18 is a proximal perspective view of another embodiment of asupport member that can be used with the connector shown in FIG. 2A orany other connector disclosed herein.

FIG. 19 is a distal perspective view of the embodiment of the supportmember shown in FIG. 18.

FIG. 20 is a section view of the embodiment of the support member shownin FIG. 18, taken through the axial centerline of the support member.

FIG. 21 is a proximal perspective view of another embodiment of a sealmember that can be used with the connector shown in FIG. 2A or any otherconnector disclosed herein.

FIG. 22 is a distal perspective view of the embodiment of the sealmember shown in FIG. 21.

FIG. 23 is a proximal perspective view of another embodiment of a sealmember that can be used with the connector shown in FIG. 2A or any otherconnector disclosed herein.

FIG. 24 is a distal perspective view of the embodiment of the sealmember shown in FIG. 23.

FIG. 25A is a proximal perspective view of another embodiment of a sealmember that can be used with the connector shown in FIG. 2A or any otherconnector disclosed herein.

FIG. 25B is a distal perspective view of the embodiment of the sealmember shown in FIG. 25A.

FIG. 26A is a perspective view of another embodiment of a support memberthat can be used with the connector shown in FIG. 2A or any otherconnector disclosed herein.

FIG. 26B is a section view of the embodiment of the support member shownin FIG. 26A.

FIG. 26C is a section view of a connector comprising the embodiment ofthe support member shown in FIG. 26A.

FIG. 26D is a section view of another embodiment of a support memberthat can be used with the connector shown in FIG. 2A or any otherconnector disclosed herein.

FIG. 27 is a proximal perspective view of another embodiment of a valveor needleless connector.

FIG. 28 is a distal perspective view of the embodiment of the connectorshown in FIG. 27.

FIG. 29 is a proximal exploded view of the embodiment of the connectorshown in FIG. 27.

FIG. 30 is a distal exploded view of the embodiment of the connectorshown in FIG. 27.

FIG. 31 is a section view of the embodiment of the connector shown inFIG. 27, showing the seal member in a first or closed position beforethe seal member has been contacted and opened by the syringe.

FIG. 32 is a section view of the embodiment of the connector shown inFIG. 27, showing the seal member in a second or open position after theseal member has been contacted and opened by the syringe.

FIG. 33 is a distal exploded perspective view of another embodiment of aconnector.

FIG. 34 is an exploded section view of the embodiment of the connectorshown in FIG. 33, taken along the axial centerline of the connector.

FIG. 35 is a section view of the seal member of the embodiment of theconnector shown in FIG. 33 when the seal element is in a second or openconfiguration, taken along the axial centerline of the seal element.

FIG. 36 is a proximal perspective view of another embodiment of a valveor needleless connector.

FIG. 37 is a distal perspective view of the connector shown in FIG. 36.

FIG. 38 is a proximal exploded perspective view of the connector shownin FIG. 36.

FIG. 39 is a distal exploded perspective view of the connector shown inFIG. 36.

FIG. 40 is an exploded section view of the connector shown in FIG. 36,taken along the axial centerline of the connector.

FIG. 41 is a section view of the connector shown in FIG. 36 and anadditional needleless connector in an unengaged configuration.

FIG. 42 is a section view of the connector shown in FIG. 36 and theadditional connector shown in FIG. 41 in an engaged configuration.

FIG. 43 is a distal perspective view of an embodiment of a dynamicvolume adjuster.

FIG. 44 is a section view of the dynamic volume adjuster shown in FIG.43 taken along the axial centerline of the dynamic volume adjuster.

FIG. 45 is a section view of a valve or needleless connector thatincludes the dynamic volume adjuster shown in FIG. 43.

FIG. 46 is a distal perspective view of an embodiment of a valve member.

FIG. 47 is a section view of the valve member shown in FIG. 46, takenalong the axial centerline of the valve member.

FIG. 48 is a section view of a valve or needleless connector thatincludes the dynamic volume adjuster shown in FIG. 46.

FIG. 49 is a section view of a valve or needleless connector thatincludes both the dynamic volume adjuster shown in FIG. 43 and the valvemember shown in FIG. 46.

FIG. 50A is a section view of an embodiment of a base member.

FIG. 50B is a section view of a valve or needleless connector thatincludes the base member shown in FIG. 50A.

FIG. 51 is a distal perspective view of an embodiment of a regulatorhaving a single slit formed therein.

FIG. 52 is a distal perspective view of an embodiment of a regulatorhaving five slits formed therein.

FIG. 53 is a distal perspective view of another embodiment of aregulator.

FIG. 54 is a section view of the regulator shown in FIG. 53 taken alongthe axial centerline of the regulator in a first direction.

FIG. 55 is a section view of the regulator shown in FIG. 53 taken alongthe axial centerline of the regulator in a second direction.

FIG. 56 is a distal perspective view of another embodiment of a valvemember.

FIG. 57 is a section view of a valve or medical connector that includesthe valve member shown in FIG. 56 in a closed configuration.

FIG. 58 is another section view of the connector shown in FIG. 57, withthe valve member in an open configuration.

FIG. 59 is a distal perspective view of another embodiment of aregulator.

FIG. 60 is a section view of the regulator shown in FIG. 59 taken alongthe axial centerline of the regulator.

FIG. 61 is a section view of a valve or needleless connector thatincludes the regulator shown in FIG. 59 in a closed configuration.

FIG. 62 is another section view of the connector shown in FIG. 61, withthe regulator in an open configuration.

FIG. 63 is a proximal perspective view of another embodiment of aregulator.

FIG. 64 is a section view of a valve or needleless connector thatincludes the regulator shown in FIG. 63 in a closed configuration.

FIG. 65 is another section view of the connector shown in FIG. 64, withthe regulator in a first open configuration.

FIG. 66 is another section view of the connector shown in FIG. 64, withthe regulator in a second open configuration.

FIG. 67 is a distal perspective view of another embodiment of aregulator.

FIG. 68 is a section view of the regulator shown in FIG. 67, taken alongthe axial centerline of the regulator.

FIG. 69 is a valve or needleless connector that includes the regulatorshown in FIG. 67 in a closed configuration.

FIG. 70 is a partial section view of the connector shown in FIG. 69,with the regulator in a first open configuration.

FIG. 71 is another partial section view of the connector shown in FIG.69, with the regulator in a second open configuration.

FIG. 72 is a section view of another embodiment of a valve or needlelessconnector support member.

FIG. 73 is a proximal perspective view of another embodiment of asupport member.

FIG. 74 is a section view of a valve or needleless connector thatincludes the support member shown in FIG. 73.

FIG. 75 is a section view of another embodiment of a support member thatincludes a bag member.

FIG. 76 is a partial section view of the support member shown in FIG.75, with the bag member in a generally collapsed configuration.

FIG. 77 is another partial section view of the support member shown inFIG. 75, with the bag member in an inflated configuration.

FIG. 78 is a side view of another embodiment of a valve or needlelessconnector.

FIG. 79 is a section view of the connector shown in FIG. 78 taken alongthe axial centerline of the connector.

FIG. 80 is a side view of another embodiment of a valve or needlelessconnector.

FIG. 81 is a section view of the connector shown in FIG. 80 taken alongthe axial centerline of the connector.

FIG. 82 is a side view of another embodiment of a valve or needlelessconnector.

FIG. 83 is a section view of the connector shown in FIG. 82 taken alongthe axial centerline of the connector.

FIG. 84 is a side view of another embodiment of a valve or needlelessconnector.

FIG. 85 is a section view of the connector shown in FIG. 84 taken alongthe axial centerline of the connector.

FIG. 86A is a side view of another embodiment of a valve or needlelessconnector.

FIG. 86B is a section view of the connector shown in FIG. 86A takenalong the axial centerline of the connector.

FIG. 87A is a side view of another embodiment of a valve or needlelessconnector.

FIG. 87B is a section view of the connector shown in FIG. 87A takenalong the axial centerline of the connector.

FIG. 88A is a side view of another embodiment of a valve or needlelessconnector.

FIG. 88B is a section view of the connector shown in FIG. 88A takenalong the axial centerline of the connector.

FIG. 89A is a side view of another embodiment of a valve or needlelessconnector.

FIG. 89B is a section view of the connector shown in FIG. 89A takenalong the axial centerline of the connector.

FIG. 90A is a side view of another embodiment of a valve or needlelessconnector.

FIG. 90B is a section view of the connector shown in FIG. 90A takenalong the axial centerline of the connector.

FIG. 91A is a side view of another embodiment of a valve or needlelessconnector.

FIG. 91B is a section view of the connector shown in FIG. 91A takenalong the axial centerline of the connector.

DETAILED DESCRIPTION OF SOME EXAMPLES OF EMBODIMENTS

The following detailed description is now directed to certain specificembodiments of the disclosure. In this description, reference is made tothe drawings wherein like parts are designated with like numeralsthroughout the description and the drawings.

In some aspects of the embodiments described herein, a variety of meansare shown for closing one or more end portions of the connectorsdescribed herein. These closing mechanisms can function to substantiallyprevent and/or substantially impede fluid from passing through the endportions of the connector when the closing mechanisms or valves are in aclosed position. When the closing mechanisms are in an open position,such as when the connector is engaged with a needleless syringe or othermedical connector, fluid is permitted to pass through one or more endportions of the connectors. As used herein, terms such as “closed” or“sealed” and variants thereof should be understood to refer toobstructions or barriers to fluid flow. These terms should not beunderstood to require that a particular structure or configurationachieves a complete fluid closure in all circumstances.

In some aspects of embodiments disclosed herein, a variety of means areshown for controlling the flow of fluid inside a connector. These fluidcontrol valves or mechanisms can facilitate the control of potentiallyundesirable fluid movement out of or into the connector. For example, itmay be desirable to prevent, inhibit, or diminish negative flow or fluidingress into the connector. As used herein, negative flow, retrogradeflow, backflow, ingress flow, and related terms are used in accordancewith their customary meanings in the medical connector field. In somecases, these terms refer to the flow of fluid into the connector due toan increase or effective increase in the internal volume of the fluidspace within the connector, or due to an external draw or removal offluid (such as by withdrawal of a portion of a medical implementpreviously inserted into the connector), or due to an external source offluid pressure in a general retrograde direction, such as that caused bya patient's cough, or by an increase in a patient's blood pressure, orby disturbances in a fluid source (e.g., fluid volume in an IV bagdiminishing or “running dry”), etc. Negative flow generally occurs in adirection generally opposite from or opposed to an intended flow offluid.

As used herein, the terms “neutral,” “neutral displacement,” “neutralflow,” and other related terms are also used in accordance with theircustomary meanings in the medical connector field. In some cases, theseterms refer to medical connectors or valves that generally do notexhibit negative flow in most clinical situations in which theparticular connectors or valves are intended to be used or thatgenerally exhibit negative flow at a sufficiently low level in mostclinical situations in which the particular connectors or valves areintended to be used that the risk of harm to a patient or the likelihoodof needing to replace the connector, valve, or catheter due to negativeflow is extremely low. Also, a neutral connector or valve generally doesnot exhibit a clinically significant positive flow of fluid emanatingfrom the distal end of the connector or valve automatically uponconnection or disconnection of another medical implement to the proximalend of the connector or valve. In some embodiments disclosed herein, theconnectors or valves can be neutral or can achieve neutral flow.

There are many sources of negative flow. These include negative flowthat occurs when a medical implement, such as a syringe, is removed fromthe proximal end, also referred to herein as the first or female end ofthe connector. As the syringe is removed, the fluid holding space insidethe connector may increase. When that fluid space is in communicationwith a patient's fluid line catheter, the increase in fluid space insidethe connector may draw fluid from the catheter into the connector fromthe distal end, also referred to herein as second or male end of theconnector. This can be disadvantageous in that such negative flow canthereby draw blood from the patient into the opposite end of thecatheter line. Such blood in the line can clot or otherwise fowl theline, possibly requiring premature replacement and reinsertion of thecatheter line, the connector, and other medical implements.

Negative flow can also come from an implement coupled to the proximalside of the connector. An example of this type of negative flow can becaused by a pump machine or by a manual syringe. For example, when themedical implement connected to the connector is a syringe, it generallyincludes an elastic plunger head connected to a plunger arm configuredto be pressed by a user or a machine. When the fluid in the syringe isexpelled, the plunger may be compressed against the end of the syringeinternal cavity. Upon release of the pressure on the plunger arm, thecompressed plunger head generally rebounds or expands slightly in theproximal direction away from the end of the cavity and, likewise, theconnector. A small void may thereby be formed between the end of thecavity and the distal surface of the plunger head. Because there isstill fluid communication with the syringe and the catheter connectingthe patient, the void can be filled with fluid pulled from the connectorwhich, in turn, can pull fluid from the catheter into the connector.This fluid drawback can also cause clotting or otherwise fowl the line.

Negative flow can occur in other ways during use, such as when an IV bagthat is used to infuse fluid through the catheter runs dry, or the bloodpressure in the patient changes, or a patient moves, etc. Negative flowcan also be produced by the momentum of fluid flow. A syringe or machinemay inject fluid into a connector. The user or machine generally dispelsas much fluid as possible into the connector, such as by pressing theplunger head all the way to the end of the internal cavity of thesyringe. Even before the pressure on the plunger is released, somenegative flow can occur into the connector. The fluid molecules areconnected by intermolecular forces and have momentum. As the finalamount of fluid is displaced from the source, it pushes fluid out of theconnector and thereby out of the catheter. As the force pushing thefluid in the distal direction ends, the fluid at the end of the cathetermay continue out of the catheter while the fluid further from the end ofthe catheter remains in the catheter. The void between the end of thecatheter and the end of the fluid column in the catheter can fill withblood which can lead to clotting.

Some embodiments of the present invention can generally eliminate,diminish, minimize, or control the effect of some or all sources ofnegative flow. Although the functionality of some of the embodimentsdisclosed herein is discussed in connection with a single source ofnegative flow (e.g., syringe rebound), it should be understood that manysources of negative flow can be eliminated, diminished, minimized, orcontrolled in similar or identical ways.

FIG. 1 illustrates examples of a variety of different components andconfigurations thereof that can be included in some embodiments of theneedleless connectors disclosed herein. FIG. 1 should not be construedto illustrate all possible combinations and/or components that can beused. Some embodiments can include a proximal end, a proximal closuresystem, an internal closure system, and a distal end, arranged in serieswith each other, as illustrated by the first series of boxes on the leftside of FIG. 1. Some embodiments can include a proximal end, a proximalclosure system, a volume adjuster, an internal closure system, and adistal end, arranged in series with each other, as illustrated by thesecond series of boxes of FIG. 1. Some embodiments can include aproximal end, a proximal closure system, an internal closure system, avolume adjuster, and a distal end, arranged in series with each other,as illustrated by the third series of boxes of FIG. 1. Some embodimentscan include a proximal end, a proximal closure system, a volumeadjuster, and a distal end, arranged in series with each other, asillustrated by the fourth series of boxes of FIG. 1. Some embodimentscan include a proximal end, a proximal closure system, a combinedinternal closure system and volume adjuster, and a distal end, arrangedin series with each other, as illustrated by the fifth series of boxesof FIG. 1. Any of these components can be omitted in certainembodiments, and components can be included in between the illustratedcomponents arranged in series with each other.

Many other combinations and other types of components can be usedinstead of or in addition to the configurations illustrated in FIG. 1.For example, some embodiments can include a proximal end, a combinedproximal closure system and volume adjuster and/or a combined proximalclosure system and internal closure system, and a distal end. In someembodiments, there can be multiple sets of the components illustrated inFIG. 1. For example, a pair of volume adjusters can be provided on bothsides of an internal closure system. In some embodiments, the distal endcan include a closure system. Any component, feature, or stepillustrated or described herein can be omitted in some embodiments. Nocomponent, feature, or step is essential or indispensable.

Several examples of proximal closure systems are illustrated, includingthe seal member 26 and support member 28 (see, e.g., FIG. 3), the sealmember 26′ (see, e.g., FIG. 21), the seal member 26″ (see, e.g., FIG.23), the seal member 326 (see, e.g., FIG. 34), the cap 491 (see, e.g.,FIG. 38), and the seal members 2126, 2226, 2326, 2426, 2526, 2626, 2726,2826, 2926, and 3026 (see, e.g., FIGS. 79, 81, 83, 85, 86B, 87B, 88B,89B, 90B, and 91B). Other types of proximal closure systems can also beused. The proximal closure systems of each embodiment can beinterchanged with those of other embodiments with appropriatemodifications (if needed). The proximal closure system can be omittedfrom some embodiments.

Several examples of volume adjusters are illustrated, including theregulators 30, 330, 630, 1030, 1130, 1230, 1430, 1530, 1730, 1930, 2130,2230, 2330, 2430, 2530, 2630, 2730, 2830, 2930, 3030 (see, e.g., FIGS.10-12, 34, 43-44, 51-53, 59-60, 63, 67-68, 74, 79, 81, 83, 85, 86B, 87B,88B, 89B, 90B, 91B), the balloon member 1830 (see, e.g., FIG. 72), andthe bag member 2030 (see, e.g., FIGS. 75-77). Other types of volumeadjusters can also be used, including others that are illustrated and/ordescribed herein. The volume adjusters of each embodiment can beinterchanged with those of other embodiments with appropriatemodifications (if needed). The volume adjuster can be omitted from someembodiments.

Several examples of internal closure systems are illustrated, includingvalve members 108, 308, 408, 730, 1008, 1108, 1208, 1330, 1408, 1508,1708 (see, e.g., FIGS. 10-12, 34, 40, 46-47, 51-53, 57, 59-60, 63,67-68), and similar valve members illustrated in FIGS. 79, 81, 83, 85,86B, 87B, 88B, 89B, 90B, and 91B). Other types of internal closuresystems can also be used, including others that are illustrated and/ordescribed herein. The internal closure systems of each embodiment can beinterchanged with those of other embodiments with appropriatemodifications (if needed). The internal closure systems can be omittedfrom some embodiments.

FIGS. 2A and 2B are perspective views of an embodiment of a valve orneedleless connector 20. FIGS. 3 and 4 are exploded views of theembodiment of the connector 20 shown in FIG. 2A. FIG. 4A is an explodedsectional view of the connector 20 shown in FIG. 2A. With reference toFIGS. 2A-4A, some embodiments of the needleless connector 20 caninclude, inter alia, a body member 22, base member 24, a seal member 26,a support member 28, and a regulator 30.

In the illustrated embodiment, the body member 22 and the base member 24can be assembled together to form a housing that substantially enclosesthe seal member 26 (also referred to herein as a first valve member),the support member 28, and the regulator 30 (also referred to herein asa second valve member). The body member 22 and the base member 24 can becoupled together with adhesive, plastic or sonic welds, snap,interference, or press-fit features, or by using any other suitablefeatures or methods. In some embodiments, the body member 22 and thebase member 24 can be coupled together using sonic welds having asubstantially triangular shape, although other shapes may also besuitable.

The body member 22, base member 24, support member 28, and any othercomponents or features of the connector 20 can be constructed from anyof a number of suitable materials. For example, the body member 22, basemember 24, support member 28, or any other suitable components orfeatures of the connector 20 can be constructed from a relatively rigidmaterial, such as polycarbonate, glassed-filled GE Valox 420,polypropylene, or other polymeric material. The body member 22, basemember 24, support member 28, and any other suitable components orfeatures of the connector 20 can also be constructed of a hydrophobicmaterial, such as Bayer Malcrolon, or any other similar or suitablematerial. One or more components of the connector 20 or any otherconnector disclosed herein can include a suitable antimicrobial agent inany appropriate form, such as a component coating, as a part of thecomponent matrix, or in any other suitable manner. In some embodiments,the antimicrobial agent may leach from or off one or more of thecomponents during use or over time. In some embodiments, theantimicrobial again can include a silver ion.

As mentioned, the support member 28 can be formed from the same type ofrigid materials as can be used to form the body member 22 or the basemember 24. In some embodiments, for example, the support member 28 canbe formed from a semi-rigid or even more flexible material than used forthe body member 22, the base member 24, or other components of theconnector 20. In some embodiments, the support member 28 (and any otherembodiment of a support member of any other connector disclosed herein)can be formed integrally with the base member 24 (or any otherembodiment of a base member of any other connector disclosed herein), orcan be formed separately and thereafter joined with the base member.

In some embodiments, the body member 22 may include one or more recessesor grooves 41 extending generally along the longitudinal direction ofthe connector 20 to facilitate the movement of the seal member 26therein. Such groves 41 can provide an area for the seal member 26 tocollapse into and can reduce the surface area in contact with the sealmember 26 when it moves within the housing.

FIGS. 5 and 6 are perspective views of the embodiment of the seal member26 in the connector 20 shown in FIG. 2A. With reference to FIGS. 1-6,the seal member 26 can be configured such that the proximal end portion34 of the seal number 26 can be sealingly received by an opening 36funned in the proximal end 162 of the body member 22. In someembodiments, as in the illustrated embodiment, the proximal end portion34 of the seal member 26 can have lip portion 38 (which can be anannular protrusion) formed thereon that is configured to contact theinside surface of the opening 36 of the body member 22 to provide a sealtherewith. The distal end 53 of the seal member 26 can include anopening 54. In some embodiments, a support member 28 can be receivedwithin the opening 54. In some embodiments, the distal end 53 furtherincludes an outwardly extending flange 56 extending around orsubstantially around the seal member 26. The flange 56 can facilitateplacement of the seal member 26 within the internal cavity of the bodymember 22 in some embodiments.

The term “proximal” is used herein to denote the end of the connector 20at or near the end of the body member 22. The term “distal” is used todenote the opposite end of the connector, e.g., the end of the connector20 at or near the end of the base member 24. In the illustratedembodiment, the proximal end is configured as a female end and thedistal end is configured as a male end. Any of the end portions,fittings, or other aspects of the connector 20 can be configured toaccommodate any standard medical connector or implement, and can beconfigured to conform with ANSI (American National Standards Institute,Washington, D.C.) or other applicable standards. The term “medicalimplement” is used herein to denote any medical device commonly used inthe medical field that can be connected or joined with any embodimentsof the connectors disclosed herein. Examples of medical implements thatare contemplated include, without limitation, tubing, biers, conduits,syringes, intravenous devices (both peripheral and central lines),closable male luer connectors (both integrally formed with a syringe orindependent connectors), pumps, piggyback lines, and other componentswhich can be used in connection with a medical valve or connector.

The seal member 26, the proximal end portion 34 of the seal member 26,and the lip portion 38 can be integrally formed or can be separatelyformed and adhered or otherwise joined together using adhesive or anysuitable material or method. In some embodiments, the seal member 26 orany other embodiment of a seal or seal member disclosed herein and anyof the components or features thereof can be constructed from a numberof different suitable materials, including silicone-based deformablematerials, rubbers, or other suitable materials. Silicone-baseddeformable materials are among those that form fluid-tight closures withplastics and other rigid polymeric materials.

The seal member 26 or any other seal member disclosed herein can beformed from one, two, or more different materials. In some embodiments,different portions of the seal member 26 can be formed from differentmaterials. For example, the seal member 26 can have a spring formedtherein (not shown) to provide some or all of the restoring forcedesired to bias the seal member 26 to the closed position. The springcan be formed from a metal such as steel, plastic, or any other suitablerigid or pliable material, and can form the core of the seal member 26such that the silicone rubber or other pliable sealing materialencapsulates the spring. In some embodiments, the seal member 26 can beconstructed just from a resilient or elastomeric material. Also by wayof example, seal member 26 may include a resilient main body portion anda separately formed resilient proximal end portion. The separate piecesmay configured to engage each other, such as for example, by coupling toa guide member with a first end configured for attachment to theproximal end portion and a second end configured for attachment to themain body portion. The guide member may be manufactured from a morerigid material than used in either or both of the main body portion andthe proximal end portion.

The seal member 26 can have a tapered resilient body portion 50 having agenerally accordion, generally wave-like, generally alternating, orgenerally undulating contour shape configured to facilitate resilientcompression and expansion of the seal member 26 as axial forces areapplied to and removed from, respectively, the proximal end portion 34of the seal member 26. In some embodiments, the body portion 50 caninclude a series of generally circular or o-ring shaped structuresintegrally formed together or separately formed and bonded together, orone or more groove structures oriented generally transverse to thedirection of compression and expansion. These structures and contourscan vary in diameter or cross-sectional shape and/or size. In someembodiments, the structures or contours can extend alternately generallyinwardly and outwardly in a direction substantially perpendicular to thelongitudinal axis of the seal member 26 (as shown, for example, in FIGS.3-6). The structure or contours can be formed in many configurations,such as in a helical configuration.

In some embodiments, the inside surface of the body portion 50 canapproximately match the outside surface of the body portion 50 such thatthe inside surface of the body portion 50 also can have the structure orcontour described elsewhere herein. In some embodiments, the insidesurface of the body portion 50 can generally extend radially inward whenthe corresponding portion of the outer surface of the body portion 50extends radially outward, and the inside surface of the body portion 50can generally extend radially outward when the corresponding portion ofthe outer surface extends radially inward. Thus, the body portion 50 cancomprise a series of bulges, wherein the thickness of the wall of thebody portion 50 alternates between thick and thin regions, as shown, forexample, in FIG. 4A. In some embodiments, the inside surface of the bodyportion 50 can generally extend radially inward when the correspondingportion of the outer surface of the body portion 50 extends radiallyinward, and the inside surface of the body portion 50 can generallyextend radially outward when the corresponding portion of the outersurface extends radially outward. Thus, the body portion 50 can comprisea series of curved segments, wherein the wall of the body portion 50 hasa more uniform thickness. In some embodiments, the inside surface of thebody portion 50 can have a relatively smooth or flat surface contour.

The body portion 50 can have a generally consistent cross-sectionalshape or size along the length thereof, or the cross-sectional shape orsize of the body portion 50 can vary along at least a portion of thelength thereof. In some embodiments, the shape of the inside of the bodyportion 50 can approximately match the outside surface of the elongatedportion 62 of the support member 28. In some embodiments, the bodyportion 50 comprises a lower section 50 a having a generally conicalshape, and an upper section 50 b having a generally cylindrical shape.Many variations are possible.

The seal member 26 can be configured so that the body portion 50 isbiased to an initial or expanded position, as illustrated in FIG. 5.When an axial force is exerted on the seal member 26, the proximal endportion 34 and/or the body portion 50 can be caused to compress to asecond position and, hence, axially retract so as to shorten the overalllength of the seal member 26. When the axial force is removed from theseal member 26, the proximal end portion 34 and/or the body portion 50can extend again as a result of the bias so as to return the seal member26 to its initial or relaxed state. Although the seal member 26 canreturn to its relaxed state in the first or closed position, the sealmember 26 can remain under some level of compression in this state, suchas, for example, where the lip 38 of the proximal end portion 34 engagesan inner surface or surfaces of the body member 22 under some degree ofaxial tension.

The seal member 26 can be configured such that the proximal end portion34 of the seal member 26 can be received by an opening 36 formed in thebody member 22. In some embodiments, as in the illustrated embodiment,the proximal end portion 34 of the seal member 26 can have a lip portion38 (which can be an annular protrusion) formed thereon that isconfigured to contact the inside surface of the opening 36 of the bodymember 22 to provide a seal therewith which generally resists theingress of particulates or fluids into the connector. As shown in FIG.3, the proximal end 162 of the body member 22 may include one or moregrooves or recesses 39 configured to permit air or fluid to flow aroundthe proximal end portion 34 of the seal member 26.

Additionally, as shown in FIG. 5, a slit or opening 52 can be formed inthe proximal end portion 34 of the seal member 26. The seal member 26can be configured so that the slit 52 is biased to a closed position, soas to substantially prevent or inhibit liquid from flowing through theslit 52 formed in the seal member 26. Additionally, in some embodiments,as will be described in greater detail below, the slit 52 can be openedby retracting the seal member 26 in the distal direction over thesupport member 28, causing at least a portion of the proximal endportion of the support member 28 to penetrate and pass through the slit52. In some embodiments, the slit 52 can be configured to open withoutthe support member 28 penetrating therethrough.

FIGS. 7 and 8 are perspective views of the embodiment of the supportmember 28 of the embodiment of the connector 20 shown in FIG. 2A. FIG. 9is a section view of the embodiment of the support member 28 shown inFIG. 7, taken through the axial centerline of the support member 28.With reference to FIGS. 7-9, in some but not all embodiments, supportmember 28 can comprise a base portion 60, an elongated portion 62projecting from the base portion 60 in the proximal direction, and adistal portion 64 projecting from the base portion 60 in the distaldirection. In some embodiments, one or more of these components of theillustrated support member 28 can be omitted or replaced with adifferent component. For example, a support member need not include anelongated portion 62. In some embodiments, the support member may besubstantially shorter, such that it does not extend into, through and/ornear the proximal end of the seal. In some embodiments of the connector20, there is no support member at all. A seal member can be configuredto open without a penetrating support member or without a support memberat all, such as when a seal member is made in a naturally open positionthat is forced to close by a smaller-diameter housing, or when a sealmember is attached to the proximal region of the housing, etc. Aregulator also can be secured or positioned within the housing and canfunction without a support member. For example, in some embodiments, theregulator 30 can be attached to the seal member and/or can be suspendedfrom another structure, or the regulator 30 can be unattached andfree-floating, without requiring the distal portion 64 or internalsupport illustrated in FIG. 13.

In some embodiments, the one or more components of the illustratedsupport member 28 can be separately formed and attached to one anothervia an adhesive, sonic welding, snap fit, or other manner. For example,the elongated portion 62 and the base portion 60 can be separatelyformed and attached by, for example, sonic welding. In some embodiments,the entire support member 28 can be integrally formed as a one-pieceunit. In some embodiments, fluid can flow through one or more holeswithin the cavity of the connector 20, such as holes positioned at ornear the distal end of the cavity, either within or outside of a sealmember or other fluid-flow impediment. Though shown as a unitary member,in some embodiments the components of the support member 28 can beseparately formed. For example, the elongated portion 62 may beseparately formed from the base member and the distal portion 64, andthe elongated portion 62 and/or any other portion can be configured tomove within the connector during use.

In some embodiments, the distal portion 64 can comprise a generallycylindrical outer surface 64 a. The longitudinal length of the distalportion 64 can be substantially shorter than the longitudinal length ofthe elongated portion 62, as illustrated. The transverse cross-sectionaldistance generally across the distal portion 64 can be less than thetransverse cross-sectional distance generally across the regulator 30(see, e.g., FIG. 12). Additionally, in some embodiments, an opening 66can be formed axially through at least a portion of the support member28. In the illustrated embodiment, the opening 66 can be in fluidcommunication with a fluid passageway 69 extending generally axiallythrough the support member 28. The fluid passageway can extend throughthe distal portion 64, base portion 60, and a substantial portion of theelongated portion 62 so that the one or more lateral or radial openings68 formed in the proximal end of the elongated portion 62 can be incommunication with the opening 66.

As illustrated in FIGS. 7-9, the elongated portion 62 can have a taperedouter surface 70 and a proximal tip portion 72. The proximal tip portion72 can have a generally tapered (or generally conical) outer surface, orcan be generally cylindrical. The elongated portion 62 can be configuredso that the proximal tip portion comprises a cross-sectional area thatis significantly less than the cross-sectional area of the base portion60 of the support member 28. In some embodiments, the proximal tipportion 72 can be configured so that the proximal end portion 34 of theseal member 26 can be retracted (e.g., from the compressed to theexpanded or initial positions) relative to the proximal tip portion 72of the support member 28 without significant drag or resistance from thesupport member 28. In some embodiments, the proximal tip portion 72 hasa sharp or rounded tip 74 configured to penetrate through the slit 52formed in the seal member 26. In some embodiments, the tip 74 isintegrally formed with the tip portion 72 and the rest of the elongatedportion 62. In some embodiments, the proximal end of the elongatedportion 62 includes a hole positioned at its proximal tip and thepassageway 69 may extend from the opening 66 to the opening at the tip.

The base portion 60 can have an outer annular wall 78 cooperating withthe distal end of the support member 28 to form an annular channel 82.The channel 82 can be configured to receive a portion of the distal endportion 56 of the seal member 26. In some embodiments, the base portion60 can be configured to secure the distal end portion 56 relative to thebase portion 60 of the support member 28 so as to prevent the distal endportion 56 from translating in a distal axial direction relative to thebase portion 60. Additionally, the channel 82 can be configured tosecure the distal end portion 56 relative to the base portion 60 of thesupport member 28 so as to prevent the distal end portion 56 fromtranslating in a radial direction relative to the base portion 60. Theseal member 26 can be assembled with the support member 28 with orwithout adhering or otherwise fixing the distal end portion 56 of theseal member 26 to the base portion 60 support member 28. Indeed, in someembodiments, the distal end of the seal member 26 can “float” in theinternal cavity of the body member 22 and can translated axially as theseal member 26 moves from a closed position to an open position.

The distal portion 64 of the support member 28 can have one or moreopenings 86 formed laterally or radially through the distal portion 64.In the illustrated embodiment, two openings 86 are formed in the distalportion 64 and are configured as generally rectangular slots with theirlong axis extending generally along the axis of the connector. However,in some embodiments, only one opening, or three, four, or more openingscan be formed in the distal portion 64 and can be formed as slots orother shaped holes. In some embodiments, the one or more openings 86 canextend along at least a majority of the longitudinal length of thedistal portion 64, as illustrated. The one or more openings 86 can beformed so as to be in communication with the axial opening 66 formed inthe support member 28.

A generally annular cavity or space 88 can be formed in the distalportion 64 of the support member 28. The annular cavity 88 can be formedbetween two annular protrusions 90, 92 formed on the distal portion 64.As will be described in greater detail below, the cavity 88 can befilled with fluid flowing through the openings 66, 86 formed in thesupport member 28. An annular protrusion 94 can also be formed at adistal end portion of the support member 28, so that a channel 96 can beformed between the annular protrusions 90, 94.

FIGS. 10 and 11 are perspective views of the embodiment of the regulator30 of the connector shown in FIG. 2A. FIG. 12 is a section view of anembodiment of a regulator 30 shown in FIG. 10, taken through the axialcenterline of the regulator 30. As illustrated in FIGS. 10-12, theregulator 30 can have a body portion 100 and a proximal end portion 102.In some embodiments, as in the illustrated embodiment, the body portion100 can be generally cylindrically shaped, and the proximal end portion102 can have an annular raised portion or lip 103 and an opening 104therethrough. In some embodiments, as illustrated, the connectorincludes a plurality of valving structures, such as the seal member 26and regulator 30, that can control fluid flow through and/or within theconnector 20.

The regulator 30 or any other embodiment of a regulator, valve, or valvemember disclosed herein and any of the components or features thereofcan be constructed from a number of different materials, includingsilicone-based deformable materials, rubbers, or other suitablematerials. Silicone-based deformable materials are among those that formfluid-tight closures with plastics and other rigid polymeric or metallicmaterials. In some embodiments, the regulator 30 can be flexible,elastomeric, and/or resilient. In some embodiments, the regulator 30 canbe made from the same material as the seal member 26. As shown in theillustrated example, a variable-volume or dynamic regulator portion ofthe regulator 30 can have a very thin, extremely flexible and/orcompliant side wall or side walls, which in some embodiments issubstantially thinner than the side wall of at least a portion of, orvirtually all of, the side wall of the seal member 26 to enable theregulator 30 to be highly responsive to fluid pressure changes.

Additionally, the regulator 30 can include a valve member at the distalend portion 108 having one or more apertures or slits 110 formedtherein, two slits 110 being shown in the illustrated embodiment. Insome embodiments, as in the illustrated embodiment, the end portion 108can comprise a valve member with a generally arcuate, generally domed,or generally spherical shape. The distal end portion 108 can beconfigured such that the distal end portion 108 is biased to a closedposition (e.g., such that the slits 110 are biased to a closedconfiguration). Therefore, in some embodiments, the distal end portion108 can be configured so as to be generally closed when the magnitude ofthe pressure differential between the fluid inside of the regulator 30and the fluid acting on the outside surface of the regulator 30 is belowa predetermined level (e.g., where the difference between the pressureexerted on the inside surface 108 a of the end portion 108 and thepressure exerted on the outside surface 108 b of the end portion 108 isbelow a predetermined level).

As illustrated, the shape of the valve member on the distal end portion108 can assist in closing the valve member more tightly as fluidpressure on the distal side of the valve member increases up to acertain level. Beyond this fluid-pressure resistance level, the valvemember can buckle or otherwise move inwardly (e.g., in the proximaldirection) to permit retrograde flow. The valve member can be configured(e.g., by selection of appropriate shape, positioning, and use ofmaterials) so that this fluid resistance level is above the pressuredifferentials normally produced by syringe rebound, proximal-end luerwithdrawal, and/or externally induced negative flow (e.g., patientcoughing, sneezing, movement, and blood pressure increases, or IV bagfluid decreases), but below the pressure differentials normally producedby intentional withdrawal of fluid from the proximal end of theconnector 20. In some embodiments, as illustrated, the valve member canbe configured to essentially retain the same initial shape as pressuredifferentials increase or build-up toward its cracking pressure to avoidor diminish communication of negative flow forces through the valvemember at pressure differentials below the cracking pressure.

In some embodiments, retrograde or negative flow can be caused byexternal effects (which are sometimes upstream from the connector 20),such as a diminished level of fluid within an IV bag, and/or jostling orother movement of a fluid line by a patient or caregiver. When the fluidin an IV bag diminishes to a low level or runs dry (or the IV bag ispositioned too low in comparison with the patient), the head pressurepreviously supplied by the IV bag also diminishes. In somecircumstances, this decrease in head pressure can render the fluid linevulnerable to “sloshing” or alternating movement of the column of fluidupstream and downstream from a connector as the patient moves around,creating periodic negative flow. In some embodiments, an internal ordistal valve member such as the valve member at the distal end 108 ofthe regulator can be configured to close when the upstream head pressurefrom a dwindling level of fluid in an IV bag falls below a thresholdlevel at which sloshing or alternating fluid movement may otherwisebegin.

In some embodiments, the valve member can be a bi-stable valve that isconfigured to open in a first direction (e.g., in the proximal-to-distaldirection) under the influence of a fluid force above a certainthreshold that is applied in the first direction and to remain open tofluid flow in that direction until a fluid force above a desiredthreshold is applied in a second direction (e.g., in thedistal-to-proximal direction), which causes the valve to open and remainopen to flow in the second direction. The bistable valve can be switchedback again from flow in the second direction to the first direction uponapplication of a force above the desired threshold in the firstdirection.

In some embodiments, one or more of the slits 110 can have a width(represented by “WS” in FIG. 12) that can be approximately equal inlength to the width of the opening 104 (represented by “WO” in FIG. 12).In some embodiments, as in the illustrated embodiment, the width WS ofone or more of the slits 110 can be smaller than the width WO of theopening 104. In some embodiments, as illustrated, the width WS, or thewidth of the transverse cross-sectional distance across the variablevolume chamber, can be substantially smaller than the longitudinallength of the variable volume chamber or substantially smaller than thelongitudinal length of the overall regulator 30. In some embodiments, asillustrated, the thickness of the wall of the regulator 30 on at least aportion of the region of the valve member at the distal end portion 108can be substantially larger than the thickness of the wall of theregulator 30 in the variable volume chamber or body portion 100 toprovide increased flexibility and compliance in the body portion 100 andincreased resistance to backflow by the valve member. In someembodiments, as illustrated, the longitudinal length of the valve memberat the distal end portion 108 can be substantially shorter than thelongitudinal length of the variable volume chamber in the body portion100 of the regulator 30 (both in embodiments in which these portions areconnected or separated).

In some embodiments, the regulator 30 can be configured such that thedistal end portion 108 of the regulator 30 will open so as to permitfluid to flow through the regulator 30 in a first direction (e.g., inthe direction from the proximal end 102 to the closure end or distal end108, represented by arrow A1 in FIG. 10) when the pressure differentialbetween the inside of the regulator 30 and the outside surface of theregulator 30 reaches a first magnitude. Similarly, the regulator 30 canbe configured such that the distal end portion 108 of the regulator 30will open so as to permit fluid to flow through the regulator 30 in asecond direction (e.g., in the direction from the closure end or distalend 108 to the proximal end 102, represented by arrow A2 in FIG. 10)when the pressure differential between the inside of the regulator 30and the outside surface of the regulator 30 reaches a second magnitude.

The valve member in the internal or distal closure system can have manydifferent shapes and configurations. For example, in some embodiments,the valve member and related attachment and positioning structure can bethe same as or similar to the valves 2200, 2250 illustrated anddescribed in at least FIGS. 50-56 and paragraphs 309-325 of U.S. PatentApplication Publication No. 2010/0049157 A1, which publication isincorporated herein in its entirety (including the cited portions) forall that it discloses.

In some embodiments, the first magnitude of the pressure differentialcan be approximately equal to the second magnitude of the pressuredifferential. In some embodiments, as in the illustrated embodiment, thefirst magnitude of the pressure differential can be less than the secondmagnitude of the pressure differential so that the regulator 30 is moreresistant to opening up to fluid flow in the second direction A2 than inthe first direction A1. In other words, the regulator 30 can beconfigured such that the end portion 108 is biased to permit flowthrough the end portion 108 in a first direction A1 at a lower pressuredifferential magnitude than in a second direction A2. In thisarrangement, the regulator 30 can inhibit backflow (e.g., flow in thedirection A2) from downstream of the regulator 30 until the magnitude ofthe pressure differential overcomes the threshold value required to openthe slits 110.

For example, without limitation, the embodiment of the regulator 30illustrated in FIGS. 10-12 can be configured so that the spherical shapeof the distal end portion 108 of the regulator 30 provides less rigidityto the end portion 108 in the first direction (represented by arrow A1)than in the second direction (represented by arrow A2). In thisconfiguration, a greater force can be required to deflect the closureend or distal end portion 108 of the regulator in the A2 direction so asto cause the slits 110 to open in the A2 direction as compared to theforce required to deflect the distal end portion 108 of the regulator inthe A1 direction so as to cause the slits 110 to open in the A1direction.

In some embodiments, the pressure of the fluid (liquid or gas) acting onthe inside surface 108 a of the regulator 30 can be approximately 0.5atmosphere greater than the pressure of the fluid (liquid or gas) actingon the outside surface 108 b of the regulator 30 for the distal endportion 108 of the regulator 30 to open in the A1 direction. In someembodiments, the pressure of the fluid acting on the inside surface 108a of the regulator 30 can be between approximately 0.1 atmosphere andapproximately 1.0 atmosphere, or between approximately 0.2 atmosphereand approximately 0.8 atmosphere, or between approximately 0.4atmosphere and approximately 0.6 atmosphere, greater than the pressureof the fluid acting on the outside surface 108 b of the regulator 30 forthe closure end or distal end portion 108 of the regulator 30 to open inthe A1 direction so as to permit fluid to flow in the A1 direction.

In some embodiments, the pressure of the fluid acting on the outsidesurface 108 b of the regulator 30 can be approximately 1 atmospheregreater than the pressure of the fluid acting on the inside surface 108a of the regulator 30 for the distal end portion 108 of the regulator 30to open in the A2 direction. In some embodiments, the pressure of thefluid acting on the outside surface 108 b of the regulator 30 can bebetween approximately 0.5 atmosphere and approximately 1.5 atmospheres,or between approximately 0.7 atmosphere and approximately 1.3atmospheres, or between approximately 0.9 atmosphere and approximately1.1 atmospheres greater than the pressure of the fluid acting on theinside surface 108 a of the regulator 30 for the distal end portion 108of the regulator 30 to open in the A2 direction so as to permit fluid toflow in the A2 direction.

In some embodiments, the magnitude of the pressure differential requiredto open the distal end portion 108 of the regulator 30 in the A2direction is approximately at least twice as large as the pressurerequired to open the distal end portion 108 of the regulator 30 in theA1 direction. In some embodiments, the magnitude of the pressuredifferential required to open the distal end portion 108 of theregulator 30 in the A2 direction is substantially larger than in the A1direction, such as at least approximately 40% greater than the pressurerequired to open the distal end portion 108 of the regulator 30 in theA1 direction. In some embodiments, including some of those illustratedherein, the magnitude of the pressure differential required to open thedistal end portion 108 of the regulator 30 in the A2 direction is lessthan approximately twice or thrice the pressure in the A1 directionrequired to open the distal end portion. In some embodiments, theregulator 30 will permit fluid flow in the A1 direction when a standardsyringe 15 is attached to the proximal end of the connector and the stemof the syringe is advanced with the amount of force normally applied forfluid transfer, but the regulator 30 will permit fluid flow in the A2direction when substantially greater retraction force is applied to thesyringe stem.

In some embodiments, at least a portion of the distal end portion 108 ofthe regulator 30 can be substantially flat, rather than being generallyspherically shaped. In some embodiments, the magnitude of the pressuredifferential required to open the regulator 30 in the A1 direction issubstantially the same as, or similar to, the magnitude of the pressuredifferential required to open the regulator 30 in the A2 direction. Insome embodiments, a flow-impeding portion, such as the distal endportion 108, of the regulator 30 can include a portion with an increasedthickness, or an indentation, on either the proximal or distal surfaceof the distal end portion 108, which can act to raise or lower themagnitude of the pressure differential required to open the regulator 30in either the A1 or A2 direction, depending on the placement thereof.Thus, in some embodiments, the regulator 30 can provide greaterresistance to fluid flow in one direction than another, such as greaterresistance in the A2 direction than the A1 direction, even if the distalend portion is substantially flat, rather than spherically shaped.

In some embodiments, the distal end portion 108 of the regulator 30 canflex inwardly, in the proximal direction, before the slits 110 crackopen to allow fluid flow in the A2 (proximal) direction. In somecircumstances, this pre-opening movement can result in a slight backflowof fluid into the distal end of the connector 20, and it can beadvantageous to reduce or eliminate this pre-opening movement of theregulator 30. In some embodiments, the spherical shape of the distal endportion 108 of the regulator can be configured to diminish or minimizethe amount that the regulator 30 moves prior to opening to allow fluidflow in the A2 direction. In some embodiments, the regulator 30 can beconfigured so that only a small volume, such as less than or equal toabout than about 0.10 ml of fluid, is displaced before the regulator 30opens for fluid flow.

Additionally, with reference to FIG. 12, the regulator 30 can furthercomprise an inner annular protrusion 112 formed on an inside surface 100a of the body portion 100. In some embodiments, the inner annularprotrusion 112 can be configured to be received within the channel 96formed between the annular protrusions 90, 94 of the support member 28.In this arrangement, the inner annular protrusion 112 can be used tosecure or support the regulator 30 in the desired axial positionrelative to the support member 28, so as to prevent or inhibit theregulator 30 from translating axially relative to the support member 28.In some embodiments, the regulator 30 is positioned within a cavity in adistal region of the connector 20 and generally or completely surroundsan internal component such as the distal end 64 of the support member28.

With reference to FIG. 12, in some embodiments, the annular protrusion112 can have a width therebetween (represented by “WP” in FIG. 12) thatcan be less than, such as about half of, the width WO of the opening104. As illustrated, the interior of the regulator 30 can include afirst cross-sectional area (e.g., in a proximal region), a secondcross-sectional area (e.g., in a mid-region), and a thirdcross-sectional area (e.g., in a distal region), wherein the secondcross-sectional area is less than each of the first and thirdcross-sectional areas. Also, an interior volume of a first or proximalregion can be substantially larger than an internal volume of a secondor distal region. In some embodiments, as in the illustrated embodiment,the width WP can be defined by the protrusion 112, which can be at leastabout one-quarter or one-half of the width WO of the opening 104.Additional features regarding the regulator 30 will be described belowwith reference to FIGS. 13-16.

FIG. 13 is a section view of the embodiment of the connector 20 shown inFIG. 2A, showing the seal member 26 in a first or closed position (e.g.,before the seal member 26 has been contacted and opened by insertion ofa luer, such as a luer on a syringe 120). FIG. 14 is a section view ofthe embodiment of the connector 20 shown in FIG. 2A, showing the sealmember 26 in a second or open position (e.g., after the seal member 26has been contacted and opened by insertion of a luer, such as a luer onthe syringe 120). In progressing between the closed and openedpositions, the seal member 26 can be configured to move. In someembodiments, as illustrated, the seal member 26 can be the closedposition. In some embodiments, the seal member 26 has a smallerlongitudinal length in the open position than in the closed position.Many other types of seal members can be used to open and close the fluidpassage within the connector in many different ways. The seal member 26can be positioned within the connector 20 so that a proximal end surface46 of the seal member 26 is generally flush or generally even with aproximal end opening of the connector 20 to permit effective antisepticwiping across the proximal end surface 46.

The syringe 120 illustrated in FIGS. 13-16 (and elsewhere in thisdisclosure) is an example of one type of medical implement that can beused with the connector 20. However, the connector 20 can be configuredfor use with a wide range of medical implements and is not limited touse with the example of the syringe 120 illustrated. The syringe 120 canbe any suitable or common medical syringe used in the medical field. Asillustrated, the syringe 120 can have a cylindrical body portion 122defining an opening 124 therein, a hollow cannula 126 projecting fromthe body portion 122, and a plunger 128 configured to be received andaxially translate within the opening 124 formed in the body portion 122.The plunger 128 can have an elastomeric or rubber seal 129 supported onthe end of the plunger 128. As is commonly done with such medicalsyringes, fluid can be expelled from the syringe 120 by forcing theplunger 128 toward the bottom surface 130 of the body portion 122, thuscausing the fluid to exit through the hollow cannula 126. In thismanner, the fluid is typically expelled from the syringe 120 until therubber seal 129 of the plunger 128 reaches the bottom surface 130 of thesyringe 120.

FIG. 15 is a schematic illustration showing the embodiment of theconnector 20 illustrated in FIG. 2A being used to inject a fluid intothe blood stream of a patient's arm. The connector 20 (or any otherembodiment of a connector disclosed herein) can be configured for a widerange of medical applications, and is not meant to be limited to the useillustrated in FIG. 15. As illustrated in FIG. 15, the connector 20 canbe joined with the conduit 132 with the other end of the conduit beingin communication with a patient's bloodstream. In this configuration,the syringe 120 can be inserted into the connector 20 so as to open theseal member 26 of the connector 20. When the seal member 26 is in anopen position, as illustrated in FIG. 14, the fluid from the syringe 120can be transferred through the connector 20 and conduit 132 and into thepatient's vasculature.

In order to inject all or substantially all of the fluid held within thesyringe 120 into the patient's vasculature, a caregiver or automatedmachine will typically depress the plunger 128 of the syringe 120 orother mechanism all the way into the body member 122 until the plunger128 and the rubber seal 129 bottoms out against the bottom surface 130of the syringe 120, which can cause the typically resilient rubber seal129 to be compressed between the generally rigid plunger 128 and thebottom surface 130 of the syringe. When this occurs, the seal 129 on theend of the plunger 128, which is typically made from a rubber or otherresilient material, can rebound when the force exerted by a caregiver onthe plunger 128 is removed.

In a conventional system (e.g., in a system not having a connector 20configured to offset the effects of the syringe rebound), when theplunger 128 and seal 129 rebound away from the bottom surface 130 of thesyringe 120, a vacuum or source of suction can be created within thesyringe 120. In some instances, the rebound effect of the plunger 128within the syringe 120 can be significant enough to allow fluids to bedrawn from within the conduit 132 and even within the patient's ownvasculature back toward the syringe 120. For example, the syringerebound can create a vacuum that can decrease the pressure within thesyringe and the connector by up to approximately 1 atmosphere.Additionally, in some cases, removal of the syringe or other medicalimplement from the connector can cause a vacuum or source of suctionwithin the connector. As used herein, the term “backflow” is usedinterchangeably with “negative flow” in some contexts to describe theinadvertent or detrimental flow of blood and/or other fluids from thepatient's vasculature into the conduit 132 and/or other components influid communication with the conduit 132.

The connector 20 can include a backflow resistance module that can beconfigured to prevent, substantially prevent, diminish, or inhibitbackflow, retrograde flow, negative flow, ingress flow, or otherpressure differential that could otherwise result from many differenttypes of sources, such as the rebound effect of the syringe 120, theremoval of at least a portion of a medical implement (such as the luerof the syringe 120) from the connector, the running dry of an IV bag,etc. In some embodiments, the backflow phenomenon can be prevented,substantially prevented, diminished, or inhibited by configuring thebackflow resistance module of the connector 20 to have a regulator, suchas a variable volume internal chamber, a volume adjuster, a dynamicvolume adjuster, or a dynamic regulator, that is configured to collapse,move, or otherwise reduce in volume to offset the vacuum effectgenerated by the syringe rebound or various other effects, and/or avalve member that is configured to prevent fluid flow in at least onedirection until a particular pressure differential threshold issurpassed. In some embodiments, as illustrated, the regulator can alsobe configured to expand, move, or otherwise increase in volume to offseta pressure differential. In some embodiments, for example, the regulator30 can be configured to perform a diaphragm-like function. Inparticular, the regulator 30 can comprise resilient, flexible, orelastomeric walls with interior surfaces that are in fluid communicationwith the fluid pathway inside the connector 20, such walls beingconfigured to buckle, flex inwardly, or otherwise move in response tothe suction or other fluid forces so as to reduce or otherwise changethe volume of space within the regulator 30 and, consequently, to permitall or a portion of the gas, liquid, or other fluid contained within theregulator 30 to flow into or out of the syringe 120 or other medicalimplement to offset a vacuum effect. As illustrated, the regulator 30can form a portion of the fluid pathway through the valve (e.g., fluidcan enter into a first end of the regulator 30 and exit from a secondend of the regulator 30). The moving wall or walls of the regulator 30can have many different configurations. For example, the wall or wallscan be resilient (as illustrated), or rigid, and/or the wall or wallscan flex or bend (as illustrated), or slide, rotate, etc. In someembodiments, the desired dynamic change in volume can be accomplished bythe interaction of generally rigid and/or generally tubular structuresin the flow path with different interior volumes. For example, suchstructures can be configured to slide in a generally co-axially,telescoping manner with respect to each other to accomplish a change influid volume.

In some embodiments, the backflow resistance module can also include avalve configured to resist fluid flow in the proximal direction. Thevalve can be a check valve or one-way valve that diminishes orsubstantially entirely prevents fluid flow in the proximal direction,such that the connector 20 can be a one-way connector under most fluidpressures commonly present in medical valves. In some embodiments, thevalve can be configured to allow fluid flow in the proximal direction ifa sufficient force is applied, such that the connector 20 can be atwo-way connector. In some embodiments, the valve can be positioneddownstream from, or distal to, the variable volume chamber. In someembodiments, for example, the distal end portion 108 of the regulator 30and the one or more slits 110 formed therein can be configured to resistfluid flow in the proximal direction, as discussed in greater detailelsewhere herein.

In some embodiments, the valve can be configured so that the forcerequired to open the valve for fluid flow in the proximal direction canbe greater than the force required to reduce the volume of the variablevolume chamber from a first volume to a second volume. For example, if apressure differential is unintentionally created (e.g., by the syringerebound effect), the variable volume chamber can shrink to offset thepressure differential while the valve can remain closed. Thus, in someembodiments, the pressure differential caused by the syringe rebound orother effect is not transferred or communicated to the fluid on thedistal side of the valve or on the distal end of the connector 20, andthe backflow of fluid is prevented.

In some embodiments, the force required to further reduce the volume ofthe variable volume chamber beyond the second volume is greater than theforce required to open the valve for fluid flow in the proximaldirection. Therefore, if a pressure differential is intentionallycreated (e.g., by a medical practitioner retracting the syringe plunger128 to draw fluid into the syringe 120), the variable volume chamber canshrink to the second volume after which the valve can open to allowfluid to flow in the proximal direction. Thus, in some embodiments, if asufficient force is applied, the backflow resistance module can beoverridden.

In the illustrated embodiment, the backflow resistance module caninclude various components of the connector 20 such as, but not limitedto, the regulator 30, the distal portion 64 of the support member 28,the inner surface of the base member 24, and the one or more openings140 formed in the base member. Many other variations are possible. Forexample, in some embodiments, the regulator 30 by itself, or anindependent flow-impeding portion 108 by itself, can be the backflowresistance module.

With reference to FIG. 13, the regulator 30 can be positioned over thedistal portion 64 of the support member 28 so as to seal the annularcavity 88 formed between the two annular protrusions 90, 92 on thedistal portion 64 of the support member 28. In this configuration, theannular cavity 88 can be sealingly bound by the annular protrusions 90,92, the outside surface 64 a of the distal end portion 64 of the supportmember 28, and the inside surface 100 a of the volume adjuster or bodyportion 100 of the regulator 30. As will be described in greater detailbelow, the volume adjuster or body portion 100 of the regulator 30 canbe configured to buckle, flex, or deform inwardly, or otherwise move, inresponse to the rebound of the plunger 128 within the syringe 120 when aportion of the gas or fluid within the cavity 88 can be drawn into thesyringe 120, or in response to a variety of other effects that mayotherwise induce an undesired level of negative pressure. A regulator orvolume adjuster can be positioned and/or oriented in many other wayswithin a connector. For example, in some embodiments, the regulator orvolume adjuster can be positioned inside of, or structured as anintegrated or unitary part of, the elongated portion 62 of the supportmember 28. In some embodiments, at least a portion of the sides of theelongated portion 62 can be flexible or otherwise moveable to producechanges in volume within the connector. In this way, the overall lengthof the connector can be diminished as compared to some of theembodiments illustrated herein.

One or more openings 86 can be formed through the distal end portion 64of the support member 28 to allow fluid to flow between the cavity 88and the opening 66 in the support member 28. In the illustratedembodiment, two openings 86 are formed through the distal end portion 64of the support member 28. Any number of any suitable or desired numbersof openings 86 can be formed in a portion 64 of the support member 28 toallow fluid to flow between the cavity 88 and the opening 66 formed inthe support member 28. In the illustrated embodiment, the openings 86are generally shaped as slots, but in other embodiments, the openings 86can have any suitable cross-sectional shape and/or size. For example, insome embodiments, the openings can have a generally circularcross-section.

Additionally, with reference to FIGS. 3, 4, and 13, the connector 20 canbe configured such that the regulator 30 is positioned in a secondcavity in the connector 20 such as the cavity 138 formed in the basemember 24. In some embodiments, the regulator 30 in an initial positioncan be tightly received within the cavity 138 formed in the base member24 so that there is very little air space, if any, between the outersurface 100 b of the body portion 100 of the regulator 30 and the insidesurface 138 a of the cavity 138.

As illustrated in FIGS. 3 and 13, one or more openings 140 can be formedthrough a portion of the base member 24 to provide an airway between theambient atmosphere and the outside surface 100 b of the body portion 100of the regulator 30. The connector 20 can be configured such that thebody member 22 does not significantly restrict the flow of air throughthe one or more openings 140. Although one opening 140 is illustrated,any suitable number of openings 140 can be formed in the base member 24.As will be described in greater detail below, the opening or openings140 can be configured to permit air to substantially freely flow intothe space between the outside surface 100 b of the regulator 30 and theinside surface 138 a of the cavity 138. In some embodiments, air cantravel between at least a portion of the interface between the bodymember 122 and the base member 124 (e.g., the portion of the interfacebelow the annular protrusion 182 and the annular channel 180) to reachthe hole 140. In some embodiments, the body member 122 can include ahole (not shown) that allows air to reach the hole 140 in the basemember 124. In some embodiments, the hole 140 in the base member can bepositioned so that is it not covered by the body member 122, but opensdirectly to the outside of the connector 20. In some embodiments, aircan leach through at least a portion of the body member 122 to reach thehole 140. In some embodiments, the base member 124 can be formed withouta hole 140, but can be configured to allow air to leach through at leasta portion of the base member 124 to reach the space between the outsidesurface 100 b of the regulator 30 and the inside surface 138 a of thecavity 138.

The regulator 30 and/or the base member 24 can be configured to seal theconnector 20 such that air flowing through the opening 140 is not ableto flow around the outside surface 100 b of the regulator 30 and intothe cavity 138 formed in the base member 24. For example, projection 90can be configured to cooperate with the resilient wall of regulator 30and the inner wall 138 a of cavity 138 to form an air tight seal to keepair that moves into the connector 20 through hole 140 effectivelycontained between inner wall surface 138 a and outer surface 100 bbetween projections 90 and 92. As will be described in greater detailbelow, the openings 140 can be configured to permit air to flow againstthe outside surface 100 b of the body portion 100 of the regulator 30 sothat the regulator 30 can substantially freely deform inwardly inresponse to the syringe rebound effect or other retrograde-flow inducingeffect, such as those described herein.

With reference to FIGS. 3, 4, and 13, additional features of the bodymember 22 and the base member 24 will now be described. In the assembledconfiguration, the seal member 26 can be supported by the support member28 so that the elongated portion 62 is received within the opening 54formed within the seal member 26. Additionally, the regulator 30 can besupported by the support member 28 so that the distal end portion 64 ofthe support member 28 is received within the opening 104 formed in theregulator 30. The seal member 26, support member 28, and the regulator30 can thus be assembled together and can be supported within the bodymember 22 and the base member 24. The body member 22 and the base member24 can be joined together to provide a rigid housing that substantiallyencapsulates the seal member 26, the support member 28, and theregulator 30 in an internal cavity 61.

The base member 24 can have a male tip protrusion 142 projectingtherefrom, the male tip protrusion 142 defining an opening 144therethrough that can be in fluid communication with the chamber 138formed inside the base portion 24. In some embodiments, as illustrated,the male tip protrusion 142 can be substantially open to fluidcommunication in both the open and closed positions of the valve.Additionally, a shroud 146 may include protrusions or other features(not shown) thereon designed to enhance the grip of the connector 20 andinternal threads 150 formed on the inside surface 146 a of the shroud146. The base member 24 can include a circumferential slot or groove 145extending around or substantially around the base member 24 to providean area of traction to be grasped by an operator. Such a groove alsopermits a more uniform wall thickness in the area of the base member 24to enhance the efficiency of manufacture. The base member 24 can beconfigured to conform with ANSI standards for medical connectors.

The body member 22 can have an annular ridge or protrusion 160 formedaround an outside surface 22 a of the body member 22 adjacent to aproximal end portion 162 of the body member 22. The proximal end portion162 can be smooth and generally cylindrical, or can have externalthreads or thread features 163 formed thereon so that the connector 20can be threadedly joined with other suitable medical implements. Theprotrusion 160 can be configured to engage a threaded collar or shroud(not shown) that may be included on a luer lock type syringe to preventor inhibit over insertion of the syringe into the connector.Additionally, with reference to FIG. 14, the inside surface 22 b of thebody member 22 can be generally smooth (as illustrated in FIGS. 13, 14).In some embodiments, the inside surface 22 b of the body member 22 cancomprise linearly arranged ridges or channels, or other such features.The channels or depressions created by the ridges can be configured toreceive portions of the seal member 26 as the seal member 26 iscompressed and expanded outwardly against such ridges or channels whenthe seal member 26 is opened. In addition, such ridges can reduce theamount of surface area in contact with the seal member as it moves inthe housing of the connector.

As illustrated in FIGS. 3 and 4, the base member 24 can comprise aproximal end portion 170 having one or more protrusions 172 positionedaround an outside surface of the proximal end portion 170 of the basemember 24. Additionally, the body member 22 can comprise a distal endportion 174 with an opening 176 extending through the entire body member22, and one or more channels or notches 178 formed in the distal endportion 174. The one or more channels or notches 178 can be configuredto receive the one or more protrusions 172 formed on the proximal endportion 170 of the base member 24. The protrusions 172 and the notches178 can be configured to substantially prevent the body member 22 fromrotating relative to the base member 24, thereby providing a more securejoint between the body member 22 and the base member 24.

Additionally, the body member 22 can include an annular channel 180formed inside the distal end portion 174 thereof, configured to receivean annular protrusion 182 formed on the proximal end portion 170 of thebase member 24. The annular channel 180 and the annular protrusion 182can be configured to provide a snap-fit type connection between the bodymember 22 and the base member 24. In this configuration, when the bodymember 22 has been joined with the base member 24 (as is illustrated inFIG. 13), the annular channel 180 and the annular protrusion 182substantially prevent the body member 22 from becoming disconnected fromthe base member 24. Many other structures and methods of attachment ofthese components can also be used.

The operation of an example of connector 20 will now be described. FIG.13 illustrates the position of the components comprising the connector20 when the seal member 26 is in the closed position (e.g., before asyringe or other medical implement has been joined with the connector20). In this configuration, the seal member 26 can be biased to theclosed position, as illustrated in FIG. 13. Additionally, the slits 110formed in the regulator 30 can be biased in the closed position asillustrated in FIG. 13.

FIG. 14 illustrates the seal member 26 in an open position in responseto the insertion of the syringe 120 being joined with the connector 20.As illustrated in FIG. 14, the luer or cannula 126 of the syringe 120 orother medical implement has been pushed in the direction represented byarrow A4 in FIG. 14 against the seal member 26 with sufficient force toovercome the bias of the seal member 26 so as to cause the seal member26 to compress or otherwise move within the body member 22. When theseal member 26 is compressed within the body member 22 to a sufficientdistance such that the end surface 46 of the seal member 26 has passedthe openings 68 formed in the support member 28, the opening 66 and/orpassageway 69 is in fluid communication with the inside of the syringe120. The force that the cannula 126 exerts on the end surface 46 of theseal member 26 can be sufficient to cause a substantially fluid-tightseal between the cannula 126 and the end surface 46 of the seal member26, so that all or substantially all of the fluid within the syringe 120is caused to flow into the opening 68 when the syringe 120 is joinedwith the connector 20 in this manner.

Thus, when the seal member 26 is in the open position, as illustrated inFIG. 14, the plunger 128 of the syringe 120 can be depressed so as toforce fluid into the connector 20. Flow arrows in FIG. 14 illustratethat, in some embodiments, when fluid is forced from the syringe 120,fluid can flow into the opening or openings 68 formed in the supportmember 28, through the passageway 69, and through the opening 66 formedin the support member 28. In some embodiments, some of the fluid canflow through the one or more openings 86 formed in the support member28, and into the chamber 88 formed between the support member 28 and theregulator 30. Additionally, if the pressure exerted on the plunger 128within the syringe 120 is sufficient to overcome the threshold pressuredifferential to open the slit or slits 110 formed in the regulator 30,fluid will also flow through the opening 144 formed in the base member24 and into another medical implement, if any, joined with the basemember 24. As illustrated, the volume capacity within the regulator 30in the stage illustrated in FIG. 14 can be approximately the same as inthe stage illustrated in FIG. 13. As discussed, when the syringe 120 orother medical implement is removed from connector 20, the connector 20can be configured such that the seal member 26 can return to the closedposition due to the bias force within the seal member 26.

FIG. 16 is a section view of the embodiment of the connector 20 shown inFIG. 2A, showing the seal member 26 in an open position and the plunger128 of the syringe 120 compressed against the bottom surface 130 of thesyringe 120. As illustrated in FIG. 16, medical practitioners orcaregivers that administer the fluid in the syringe 120 to a patienttypically depress the plunger 128 against the bottom surface 130 of thesyringe so as to expel substantially all of the fluid from the syringeinto the connector, causing the commonly resilient seal 129 on the endof the plunger 128 to compress between the substantially rigid plunger128 and the substantially rigid bottom surface 130 of the syringe. Asillustrated, the volume capacity within the regulator 30 in the stageillustrated in FIG. 16 can be approximately the same as in the stageillustrated in FIGS. 13 and 14.

In this position, when the plunger 128 has been completely depressedrelative to the syringe 120 such that no additional fluid is beingforced from the syringe 120, the fluid flow within the syringe 120 and,hence, the connector 20, stops. With no fluid flowing through theconnector 20, the fluid pressure differential between the fluid withinthe connector 20 and the fluid outside of the connector 20 (e.g., in acatheter that is in fluid communication with the distal end of theconnector 20) falls below the threshold value required to open or keepopen the slit or slits 110 in the regulator 30, and the slit or slits110 close so that no additional fluid passes through the regulator 30,until the pressure differential again exceeds the threshold required toopen the slit or slits 110.

FIG. 17 is a section view of the embodiment of the connector 20 shown inFIG. 2A, showing the seal member 26 in an open position and the syringe120 after the plunger 128 of the syringe 120 has rebounded away from thebottom surface 130 of the syringe 120. After the rubber seal 129 on theend of the plunger 128 has been depressed against the bottom surface 130of the syringe 120 such that substantially all of the fluid has beenexpelled from the syringe 120 and the caregiver releases the plunger128, the resilient seal 129 on the end of the plunger 128 typicallycauses the plunger 128 to rebound away (as illustrated) or expand upwardfrom the bottom surface 130 of the syringe. When this occurs, a volumeof space is created between the seal 129 and the bottom surface 130 ofthe syringe 120, causing a vacuum to be created in the syringe 120.

With reference to FIG. 17, the connector 20 can be configured tocompensate for the syringe rebound effect so that the pressuredifferential between the fluid inside the connector 20 relative to thefluid outside of the connector 20 can be less than the thresholdpressure differential required to open the slit or slits 110 formed inthe regulator 30.

For example, after the plunger 128 has moved away from the bottomsurface 130 of the syringe 120 or expanded in the direction representedby arrow A5 (e.g., after the plunger 128 has rebounded), the connector20 can compensate for the vacuum created within the syringe 120. Asillustrated in FIG. 17, the regulator 30 can be configured such that thevolume adjuster or body portion 100 of the regulator 30 can deflectinwardly into the one or more chambers 88 in response to the vacuumcreated within the syringe 120, so as to reduce the volume of thechamber 88, and hence reduce the volume of space within the connector20. As illustrated, the volume capacity within the regulator 30 in thestage illustrated in FIG. 17 can be less than the volume capacity withinthe regulator 30 in the stages illustrated in FIGS. 13, 14, and 16(e.g., by approximately the amount of fluid that has re-entered thesyringe 120 as a result of the rebound of the plunger 128).

In some embodiments, as illustrated, a regulator, such as a dynamicregulator, variable volume chamber, or volume adjuster, can move todiminish, generally eliminate, or generally counteract a vacuum orpressure differential by inducing a corresponding and opposing change involume that has substantially the same magnitude or size as, and/or thatoccurs at substantially the same time as, the vacuum or pressuredifferential that would otherwise produce a negative or retrograde flow.In some embodiments, as illustrated, the regulator 30 can be configuredto provide a plurality of different volume adjustments (e.g., acontinuously variable volume adjustment within a clinically relevantrange) to enable the regulator to respond to a plurality of differenteffects that may otherwise cause varying amounts of vacuum or pressuredifferential that would produce negative or retrograde flow. The volumeadjustment of the regulator 30 can be enabled or configured to occurautomatically and independently of the movement of other components ofthe valve. For example, as illustrated, the volume change in theregulator 30 between the stages illustrated in FIGS. 16 and 17 does notnecessarily depend on or require the connector 20 to be moving betweenthe closed and opened positions; rather, the position of the proximalclosure system (e.g., the seal 26 in relation to the support member 28)can be essentially the same in these stages. As illustrated, in someembodiments, the seal member 26 can be spaced from and disconnected fromthe regulator 30 in either or both of the open and closed positions.

As the regulator 30 changes its volume, the volume of fluid (gas orliquid) within the chamber 88 that is displaced by the change in volumeof the chamber 88 can flow into the syringe 120 or other medicalimplement attached to the connector 20. In some embodiments, the closureend portion 108 of the regulator 30 can remain closed while theregulator 30 adjusts the fluid volume capacity inside of the connector20. In some embodiments, the body portion 100 of the regulator 30 can beconfigured to move independent of the movement of the seal member 26. Asshown, for example, in FIGS. 16 and 17, the body portion 100 of theregulator 30 can deflect inwardly while the seal member 26 remainssubstantially still in the collapsed configuration. In some embodiments,the seal member 26 and the regulator 30 can be combined in an integralor unity component, and/or the seal member 26 can be appropriatelyconfigured to include some or all of the features of the regulator 30.

In some embodiments, as illustrated, the regulator 30 can primarilyexpand and contract, or otherwise move, in a direction that is generallytransverse to the fluid flow axis through the connector 20, withoutgenerally expanding or contracting by a significant amount (or at all)in a direction that is generally parallel with the fluid flow axisthrough the connector 20. In some embodiments, as illustrated, thediameter and/or cross-sectional area of the variable volume portion orbody portion 100 of the regulator 30 can be generally constant betweenproximal and distal ends thereof in an initial position.

Thus, the connector 20 and, in particular, the regulator 30, can beconfigured such that, when the syringe 120 rebounds, the pressuredifferential between the fluid within the connector 20 and the fluidoutside of the connector 20 can be dynamically maintained below thethreshold pressure differential required to open the slit or slits 110in the regulator 30 by reducing the volume within the connector 20 evenbefore the seal member 26 closes, thus mitigating the vacuum suction orretrograde fluid flow within the syringe. Additionally, in someembodiments, the end portion 108 of the regulator 30 can be configuredto deflect inwardly slightly without the slit or slits 110 opening, toaccount for the vacuum generated by the syringe rebound.

In some embodiments, the connector 20 and the regulator 30 can beconfigured to compensate for a vacuum of at least approximately 1atmosphere within the syringe 120 without the regulator 30 opening. Insome embodiments, the connector 20 and the regulator 30 can beconfigured to compensate for a vacuum of between approximately 0.5atmospheres and approximately 3 atmospheres, or between approximately 1atmosphere and approximately 2 atmospheres within the syringe 120without the regulator 30 opening.

After the desired amount of fluid has been dispensed from the syringe120 or other medical implement, the syringe 120 or other medicalimplement can be removed from the connector 20. When the syringe 120 orother medical implement is removed from connector 20, the connector 20can be configured such that the seal member 26 can return to the closedposition due to the bias force within the seal member 26. Thisreversibility of the seal member 26 makes the connector 20 particularlyattractive as a connector valve to provide fluid communication betweentwo fluid lines. Since the connector 20 can be sealed closed and can bedisinfected, various syringes or medical implements can be easily joinedwith the connector 20 multiple times without requiring removal of theconnector 20 from communication with the patient's vasculature.

The removal of the luer of a medical implement, such as the syringe 120can also cause backflow or negative flow into the connector 20. As shownin FIG. 17A, regulator 30 can be configured to inhibit or prevent thisnegative flow as well. As shown, the regulator 30 may be sized toaccommodate additional inward flex or other movement even after thesyringe rebound effect shown in FIG. 17. Thus, the side wall 100 of theregulator 30 continues to collapse inwardly as the syringe 120 isremoved from the connector 20 to maintain a pressure differential lessthan the cracking pressure needed to open the slits 110 and thereforethe regulator 30. As illustrated, the volume capacity within theregulator 30 in the stage illustrated in FIG. 17 can be less than thevolume capacities within the regulator 30 in the stages illustrated inFIGS. 13, 14, 16, and 17A. Since the regulator 30 remains closed,essentially no fluid is drawn into the distal end of the connector 20,essentially no fluid is drawn into the catheter or other medicalimplement attached to the distal end of the connector, and therefore,essentially no negative flow is created. In some embodiments, thevariable volume within the regulator 30 can vary by at least about 0.01ml and/or less than or equal to about 0.10 ml, although in manyembodiments, the volume can vary by amounts outside this range,depending on the configuration (e.g., amount of dead space) within theconnector. In some embodiments, the variable volume of the variablevolume chamber is at least about 0.02 cc and/or less than or equal toabout 0.06 cc. In some embodiments, the variable volume of the variablevolume chamber is about 0.04 cc.

In some embodiments, as illustrated in FIGS. 17 and 17A, even after theregulator 30 moves to compensate or respond to a change in pressure orfluid volume, some amount of fluid can still remain within the regulator30, including within the fluid cavity 88 between the outer surface ofthe distal portion 64 of the support member 28 and the inner surface ofthe volume adjuster of the body portion 100 of the regulator 30

In some embodiments, as illustrated in FIG. 17A, the volume adjustmentof the regulator 30 can be permitted to occur independently of themovement of other components of the valve (such as the proximal closuresystem). For example, the volume change in the regulator 30 between thestages illustrated in FIGS. 17A and 17B does not necessarily depend onor require that the connector 20 is moving between the closed and openedpositions; rather, the change in volume in the regulator 30 can occurbecause the regulator 30 automatically responds to pressuredifferentials communicated through the fluid, but not necessarilybecause the regulator is mechanically or directly linked to othercomponents within the connector 20. In some embodiments, there can be adirect or mechanical connection between the regulator 30 and othercomponents, including the proximal closure system.

In some embodiments (not shown), the regulator 30 can be configured toinclude a rigid chamber instead of the flexible, resilient body portion100 described elsewhere herein. For example, the regulator 30 can beconfigured to have a resilient end portion defining one or more slits oropenings in the end thereof, similar to the regulator 30, but having abody portion that is not configured to buckle or deflect inwardly inresponse to the syringe rebound or other retrograde-inducing event.Rather, in some embodiments, a regulator (not shown) could be configuredto slide axially within the chamber 138 formed within the base member24, but to be biased by a spring member away from the support member. Inthese and other embodiments, the support member can be formed withoutthe distal end portion 64. In such configurations, when the vacuum isformed within the syringe, the regulator can be configured to slidetoward the syringe, against the force of the bias, so as to reduce thevolume within the connector and prevent the slit or slits in theregulator from opening. In some embodiments, the variable volume cavityor dynamic volume adjuster of the regulator 30 can comprise a flaccidbag or other flaccid fluid container that is generally not resilient andgenerally not stretchable. The container can be made of very softpolyethylene or other materials, and can be configured to selectivelypermit fluid ingress and/or egress by filling up without necessarilycausing a stretching of the walls of the container.

In some embodiments (not illustrated), the regulator can be positionedadjacent to the inside surface of the opening 66 formed in the distalend portion 64 of the support member 28 so as to line or be positionedgenerally within at least a portion of the inside surface of the opening66 and the passageway 69 extending inside the distal end portion 64 ofthe support member 28, or adjacent to the inside surface of anothermember having an internal opening in fluid communication with theopening 66. For example, in some embodiments, the regulator can cover aportion of the inside surface of a hollow, cylindrical member whereinthe opening through the cylindrical member is in communication with theopening 66. In some embodiments, at least a portion of the regulator(e.g., a middle portion) can be unrestrained so as to be permitted tobuckle inwardly or otherwise move in response to the vacuum from thesyringe, disconnection of the syringe or other medical implement fromthe connector, or otherwise. The size or diameter of the opening 66formed in the distal end portion 64 of the support member 28 can beincreased to accommodate the regulator positioned adjacent to the insidesurface thereof. As mentioned, in some embodiments (not illustrated),the regulator can comprise cylindrical sidewalls configured to buckleinwardly to reduce the internal volume, and hence the internal pressurewithin the connector so as to compensate for the vacuum created by thesyringe rebound or disconnection of the medical implement. As with theother embodiments described herein, the connector can have an air porttherein that is sealed from the opening 66 and the fluid passing throughthe connector, but which permits the regulator to freely slide axially,or buckle or collapse inwardly. When a medical implement, such as theluer tip 126 of the syringe 120, is reinserted into the proximal end ofthe connector 20 in the closed state after the introduction of fluid(e.g., the state illustrated in FIG. 17A), the fluid volume within theconnector 20 may again change. In this situation, the fluid volumewithin the connector 20 may increase, causing the variable volume withinthe regulator 30 to increase by forcing the sidewalls to expandoutwardly or otherwise move. Since the regulator 30 can thus absorb thevolume differential, the valve member 138 can remain closed duringreinsertion, and fluid flow toward the patient upon reinsertion of theluer tip 126 can be substantially or entirely eliminated. In some cases,the positive flow of fluid that would otherwise be caused by thereinsertion of a medical implement is not desirable and can be avoided,especially for patients with a comparatively small blood volume, such asneonatal patients. After reinsertion of the medical implement, theconnector 20 can progress to one or more states with variable internalvolumes that are different from that illustrated in FIG. 17A, such asstates similar to those illustrated in FIGS. 16 and 17.

In some embodiments, as illustrated in FIGS. 13-17A, the valve member onthe distal end portion 108 of the regulator 30 can generally preventmany forms of internally or externally generated negative flow or fluidingress. The dynamically adjusting volume of the body 100 of theregulator 30 can permit the valve member on the distal end portion 108to remain closed even when fluid volume is withdrawn or changes, and canallow usage of a valve member on the distal end portion 108 that isconfigured to permit a substantially lower threshold for fluid flow inthe proximal direction. In some embodiments, as illustrated, thethreshold pressure differential required to open the valve member tofluid flow in the proximal-to-distal direction is substantially lowerthan the threshold pressure differential required to open the valvemember to fluid flow in the distal-to-proximal direction. Also, thevalve member on the distal end portion 108 can be configured togenerally prevent negative flow or retrograde flow caused by externalsources on the distal side of the connector 20.

FIGS. 18 and 19 are perspective views of another embodiment of a supportmember 28′ that can be used with the connector 20 shown in FIG. 2A orany other connector disclosed herein. FIG. 20 is a section view of theembodiment of the support member 28′ shown in FIG. 18, taken through theaxial centerline of the support member 28′. In some embodiments, thesupport member 28′ can have any of the features or other details orconfigurations of the support member 28. Additionally, the supportmember 28′ can be configured to operate with the body member 22, thebase member 24, the seal member 26, or the regulator 30. Thus, in someembodiments, the support member 28′ can be interchanged with the supportmember 28. Many features of the support member 28′ illustrated in FIGS.18-20 can be the same as or similar to the corresponding features of thesupport member 28.

As illustrated in FIGS. 18-20, the distal portion 64′ of the supportmember 28′ can have one or more openings 86′ formed laterally orradially through the distal portion 64′. In the illustrated embodiment,two openings 86′ are formed in the distal portion 64′. However, in someembodiments, only one opening, or three, four, or more openings can beformed in the distal portion 64′. The openings 86′ can be formed so asto be in communication with the axial opening 66′ and the fluidpassageway 69′ formed in the support member 28′. Similar to the supportmember 28, the opening 66′ can be in communication with the one or moreopenings 68′ formed in the proximal tip portion 62′ of the supportmember 28.

Additionally, the support member 28′ can have one or more depressions87′ formed in the distal end portion 64′ of the support member 28′, theone or more depressions 87′ being formed so as to be in fluidcommunication with the one or more openings 86′ formed in the distal endportion 64′. The one or more smoothly contoured depressions 87′ caninclude one or more generally round, generally parabolically shapedcavities 88′ that can be filled with fluid flowing through the openings66′, 86′ formed in the support member 28′ in a manner similar to thecavities 88 of the support member 28. Similar to the support member 28,the distal end portion 64′ of the support member 28′ can be configuredto be received within the opening 104 formed within the regulator 30,and hence support the regulator 30 in a similar fashion as has beendescribed with reference to the connector 20.

The support member 28′ can function in the same or similar manner ascompared to the support member 28. In particular, when syringe rebound,or other force, generates a vacuum within the syringe, the body portion100 of the regulator 30 can deflect inwardly into the cavities 88′ inresponse to the vacuum created within the syringe 120. This can cause areduction in the volume of the chamber 88′, and hence reduce the volumeof space within the connector 20. As this occurs, the volume of fluid(gas or liquid) within the chamber or chambers 88′ that is displaced bythe change in volume of the chamber or chambers 88′ can flow into thesyringe 120, thereby mitigating the effects of the vacuum within thesyringe as described herein.

FIGS. 21 and 22 are perspective views of another embodiment of a sealmember 26′ that can be used with the connector 20 shown in FIG. 2A orany other connector disclosed herein. In some embodiments, the sealmember 26′ can have any of the features or other details orconfigurations of the seal member 26 or any other seal member describedherein. The seal member 26′ can be configured to operate with the bodymember 22, the base member 24, the support member 28, or the regulator30. Thus, in some embodiments, the seal member 26′ can be interchangedwith the seal member 26. In some embodiments, the internal wallstructure of the body member 22, (including but not limited to theinside abutment surface 164), can be slightly modified to accommodatethe different configuration of the seal member 26′. For example, theinside abutment surface 264 of the body member illustrated in FIGS.27-32 can be oriented at a generally shallow angle (e.g., less thanabout 45°) from the horizontal plane.

The seal member 26′ can include an annular collar portion 42′ having aproximal face 44′. In some embodiments, as will be described in greaterdetail below, the collar portion 42′ can be configured to interact withan inside surface of the body member 22 (which can be an annularprotrusion, one or more tabs, or other protruding feature) so as tolimit the axial movement of the proximal end portion 34′ of the sealmember 26′ in the proximal direction. In some embodiments, the bodymember 22 and the seal member 26′ can be configured so that the endsurface 46′ (which can be planar) of the seal member 26′ can be adjacentto or approximately coplanar with the end surface 48 of the body member22, when the seal member 26′ is in the closed position. The first orclosed position of the seal member 26′ relative to the body member 22 isillustrated in FIG. 2A. This approximate alignment of the proximalsurfaces can make it easier to clean and disinfect the seal member andother components of the connector 20. The seal member 26′ and bodymember 22 can thus be configured so that the end surface 46′ can beconsistently aligned generally with the end surface 48 of the bodymember 22 when the seal member 26′ is in the closed position.

As with seal member 26, seal member 26′ can have a resilient bodyportion 50′ having a shape as previously described configured to permitthe seal member 26′ to resiliently compress and expand as axial forcesare applied to and removed from, respectively, the proximal end portion34′ of the seal member 26′. In some embodiments, the body portion 50′can include a series of o-ring shaped structures integrally formedtogether or separately formed and bonded together. The o-rings can varyin diameter or cross-sectional shape and/or size.

In some embodiments, the inside surface of the body portion 50′ canapproximately match the outside surface of the body portion 50′. In someembodiments, the inside surface of the body portion 50′ can have arelatively smooth or flat surface contour. The body portion 50′ can havea generally consistent cross-sectional shape or size along the lengththereof, or the cross-sectional shape or size of the body portion 50′can vary along at least a portion of the length thereof. In someembodiments, the shape of the inside of the body portion 50′ canapproximately match the outside surface of the elongated portion 62 ofthe support member 28. Seal member 26′ can move from the first to secondposition in a similar manner to the seal member 26. In the closedposition, seal member 26′ can remain under some additional level ofcompression, such as, for example, where the proximal face 44′ of thecollar portion 42′ engages an inner surface or surfaces of the bodymember 22

The body member 22 can comprise an inside abutment surface 164 that canbe configured to interact with the corresponding annular collar portion42′ formed on the seal member 26′. The abutment surface 164 and annularcollar portion 42′ formed on the body member 22 and the seal member 26′,respectively, can be configured to limit the motion of the seal member26′ relative to the body member 22 in the proximal direction (e.g., thedirection represented by arrow A3 shown in FIG. 14). In someembodiments, the abutment surface 164 and the annular collar portion 42′formed on the body member 22′ and the seal member 26′, respectively, canbe configured to stop the seal member 26′ at the approximate positionwhere the end surface 46′ of the seal member 26′ can be adjacent to orapproximately coplanar with the end surface 48 of the body member 22.The end surface 46′ of the seal member 26′ can thereby be prevented fromprotruding past the end surface 48 of the body member 22, or protrudingpast the end surface 48 in a consistent manner, e.g. to a consistentdistance beyond the end surface 48 during various valve activations.

The seal member 26′ can be configured such that the proximal end portion34′ of the seal number 26′ can be sealingly received by an opening 36formed in the body member 22. In some embodiments, as in the illustratedembodiment, the proximal end portion 34′ of the seal member 26′ can havea lip portion 38′ (which can be an annular protrusion) formed thereonthat is configured to contact the inside surface of the opening 36 ofthe body member 22 to provide a seal therewith.

The seal member 26′, the proximal end portion 34′ of the seal member26′, and the lip portion 38′ can be integrally formed or can beseparately formed and adhered or otherwise joined together usingadhesive or any suitable material or method. In some embodiments, theseal member 26′ or any other embodiment of a seal or seal memberdisclosed herein and any of the components or features thereof can beconstructed from a number of different suitable materials, includingsilicone-based deformable materials, rubbers, or other suitablematerials. Silicone-based deformable materials are among those that formfluid-tight closures with plastics and other rigid polymeric materials.

Similar to the seal member 26, the seal member 26′ can be configured sothat the body portion 50′ is biased to an expanded or initial position.When an axial force is exerted on the seal member 26′, the body portion50′ can be caused to compress and, hence, axially retract so as toshorten the overall length of the seal member 26′. When the axial forceis removed from the seal member 26′, the body portion 50′ can expand asa result of the bias so as to return the seal member 26′ to its initialor relaxed state.

Additionally, as shown in FIG. 21, a slit or opening 52′ can be formedin the proximal end portion 34′ of the seal member 26′. The seal member26 can be configured so that the slit 52′ is biased to a closedposition, so as to substantially prevent or inhibit any liquid fromflowing through the slit 52′ or the opening 54′ formed in the sealmember 26′. Additionally, as will be described in greater detail below,in some embodiments, the slit 52′ can be opened by retracting the sealmember 26′ in the distal direction over the support member 28, causingat least a portion of the proximal end portion of the support member 28to penetrate and pass through the slit 52′.

FIGS. 23, 24 are perspective views of another embodiment of a sealmember 26″ that can be used with the connector 20 shown in FIG. 2A orany other connector disclosed herein. In some embodiments, the sealmember 26″ can have any of the features or other details orconfigurations of the seal member 26 or the seal member 26′. The sealmember 26″ can be configured to operate with the body member 22, thebase member 24, the support member 28, or the regulator 30. Further, aswill be described, the seal member 26″ can be configured to operate withthe body member 22, the base member 24, an embodiment of a supportmember 28 not having the elongated portion 62 (not illustrated), and theregulator 30. In particular, because the seal member 26″ can beconfigured to open and close without the use of the elongated portion 62of the support member 28, in some embodiments of the connector 20 (notillustrated), the seal member 26″ can operate without the inclusion ofthe elongated portion 62.

Thus, in some embodiments, the seal member 26″ can be interchanged withthe seal member 26 or the seal member 26′. In some embodiments, theinternal wall structure of the body member 22, including but not limitedto the inside abutment surface 164, may need to be slightly modified toaccommodate the different configuration of the seal member 26″. Manyfeatures of the seal member 26″ illustrated in FIG. 23 can be the sameas or similar to the corresponding features of the seal member 26.

As illustrated in FIG. 23, the seal member 26″ can be configured suchthat the proximal end portion 34″ of the seal member 26″ can besealingly received by an opening 36 formed in the body member 22. Theseal member 26″ can be configured such that the proximal end portion 34″and/or the end surface 46″ of the seal number 26″ can have a generallyovular or elliptical shape. In some embodiments, the end surface 46″ ofthe seal number 26″ can have a first length or dimension (represented bylength D1 in FIG. 23) and a second length or dimension (represented bylength D2 in FIG. 23), the second length D2 being less than the firstlength D1. In some embodiments, the length D1 can be at leastapproximately one-quarter or at least approximately one-third greaterthan length D2. As mentioned, in some embodiments, the shape of thecross-section of the proximal end portion 34″ can be similar to theshape of the end surface 46″ of the seal number 26″.

Additionally, as shown in FIG. 23, a slit or opening 52″ can be formedin the proximal end portion 34″ of the seal member 26″. The seal member26″ can be configured so that the opening 52″ is biased to an openposition (as illustrated) when the seal member 26″ is in a relaxedstate, so as to permit liquid to flow through the opening 52″ and,hence, the opening 54″ formed in the seal member 26″. The opening 52″can be configured such that, when generally mutually opposing such as,but not limited to, forces F1 and F2 shown in FIG. 23, are applied tothe proximal end portion 34″ of the seal member 26″, the opening 52″will be sealingly closed so as to substantially inhibit or prevent anyfluid flow therethrough.

Therefore, the opening 36 in the body member 22 can be configured tohave a substantially circular cross-section so that, as the proximal endportion 34″ of the seal member 26″ is inserted into the opening 36 ofthe body member 22, the substantially rigid and circular opening 36 canexert a force on the proximal end portion 34″ of the seal member 26″that can close the opening 52″ so as to substantially inhibit the flowof fluid through the opening 52″. The body member 22 can also beconfigured such that, as the proximal end portion 34″ of the seal member26″ is compressed and, hence, retracted away from the opening 36 (suchas by the insertion of a syringe or other medical implement), theproximal end portion 34″ of the seal member 26″ will no longer berestrained by the openings 36 of the body member 22, such that the biasof the proximal end portion 34″ will cause the opening 52″ to open andpermit fluid flow therethrough.

Therefore, in this configuration, the connector can operate as desiredwithout the use of the elongated portion 62 of the support member 28.However, in some embodiments, the seal member 26″ can be used with asupport member 28 having an elongated portion 62, wherein the slit oropening 52″ can also be opened by retracting the seal member 26″ in thedistal direction over the support member 28, causing at least a portionof the proximal end portion of the support member 28 to penetrate andpass through the slit 52″. In some embodiments, as with otherembodiments of the seal member, the proximal end portion 34″ of the sealmember 26 can have a lip portion 38″ (which can be an annularprotrusion) formed thereon that is configured to contact the insidesurface of the opening 36 of the body member 22 to provide a sealtherewith.

The seal member 26″, the proximal end portion 34″ of the seal member26″, and the lip portion 38″ can be integrally formed or can beseparately formed and adhered or otherwise joined together usingadhesive or any suitable material or method. In some embodiments, theseal member 26″ or any other embodiment of a seal or seal memberdisclosed herein and any of the components or features thereof can beconstructed from a number of different suitable materials, includingsilicone-based deformable materials, rubbers, or other suitablematerials. Silicone-based deformable materials are among those that formfluid-tight closures with plastics and other rigid polymeric materials.

The seal member 26″ can have a resilient body portion 50″ having aplurality of accordion-like structures configured to permit the sealmember 26″ to resiliently compress and expand as axial forces areapplied to the proximal end portion 34″ of the seal member 26″. The bodyportion 50″ can have a generally consistent cross-sectional shapethroughout the length thereof (as illustrated), or the cross-section ofthe body portion 50″ can vary along a portion of the length thereof (notillustrated), similar to the seal member 26′. In some embodiments, theshape of the inside of the body portion 50″ can approximately match theoutside surface of the elongated portion 62 of the support member 28, ifsuch elongated portion 62 is present.

Similar to the seal member 26, the seal member 26″ can be configured sothat the body portion 50″ is biased to an expanded or initial position.When an axial force is exerted on the seal member 26″, the body portion50″ can be caused to compress and, hence, axially retract so as toshorten the overall length of the seal member 26″. When the axial forceis removed from the seal member 26″, the body portion 50″ can expand asa result of the bias so as to return the seal member 26″ to its relaxedstate.

FIGS. 25A and 25B are perspective views of another embodiment of a sealmember 26′″ that can be used with the connector shown in FIG. 2A or anyother connector disclosed herein. In some embodiments, the seal member26′″ can have any of the features or other details or configurations ofthe seal member 26 or any other seal member described herein. The sealmember 26′″ can be configured to operate with the body member 22, thebase member 24, the support member 28, or the regulator 30. Thus, insome embodiments, the seal member 26′″ can be interchanged with the sealmember 26. Many features of the seal member 26′″ illustrated in FIGS.25A and 25B can be the same as or similar to the corresponding featuresof the seal member 26.

The seal member 26′″ can be configured such that the proximal endportion 34′″ of the seal number 26′″ can be sealingly received by anopening 36 formed in the body member 22. The proximal end portion 34′″can be generally cylindrical with a generally smooth sidewall. In someembodiments, as in the illustrated embodiment, the proximal end portion34′″ of the seal member 26 can have a lip portion 38′″ (which can be anannular protrusion) formed thereon that is configured to contact theinside surface of the opening 36 of the body member 22 to provide a sealtherewith.

The seal member 26 can also comprise an annular collar portion 42′″having a proximal face 44′″. In some embodiments, the collar portion42′″ can be configured to interact with an inside surface of the bodymember 22 (which can be an annular protrusion, one or more tabs, orother protruding feature) so as to limit the axial movement of theproximal end portion 34′″ of the seal member 26′″ in the proximaldirection. In some embodiments, the body member 22′″ and the seal member26′″ can be configured so that the end surface 46′″ (which can beplanar) of the seal member 26′″ can be adjacent to or approximatelycoplanar with the end surface 48′″ of the body member 22, when the sealmember 26′″ is in the closed position. This approximate alignment canmake it easier to clean and disinfect the seal member and othercomponents of the connector 20. The seal member 26′″ and body member 22can thus be configured so that the end surface 46′″ can be consistentlyaligned generally with the end surface 48 of the body member 22 when theseal member 26′″ is in the closed position.

The seal member 26′″, the proximal end portion 34′″ of the seal member26′″, and the lip portion 38′″ can be integrally formed or can beseparately formed and adhered or otherwise joined together usingadhesive or any suitable material or method. In some embodiments, theseal member 26′″ or any other embodiment of a seal or seal memberdisclosed herein and any of the components or features thereof can beconstructed from a number of different suitable materials, includingsilicone-based deformable materials, rubbers, or other suitablematerials. Silicone-based deformable materials are among those that formfluid-tight closures with plastics and other rigid polymeric materials.

The seal member 26′″ can have a resilient body portion 50′″ having acontour as described in other seal embodiments that is configured topermit the seal member 26′″ to resiliently compress and expand as axialforces are applied to and removed from, respectively, the proximal endportion 34 of the seal member 26′″. In some embodiments, the insidesurface of the body portion 50′″ can approximately match the outsidesurface of the body portion 50′″. In some embodiments, the insidesurface of the body portion 50′″ can have a relatively smooth or flatsurface contour. In some embodiments, the body portion 50′″ can have agenerally consistent cross-sectional shape or size along the lengththereof, or the cross-sectional shape or size of the body portion 50′″can vary along at least a portion of the length thereof. In someembodiments, the shape of the inside of the body portion 50′″ canapproximately match the outside surface of the elongated portion 62 ofthe support member 28.

Similar to the seal member 26, the seal member 26′″ can be configured sothat the body portion 50′″ is biased to an expanded or initial position.When an axial force is exerted on the seal member 26′″, the body portion50′″ can be caused to compress and, hence, axially retract so as toshorten the overall length of the seal member 26′″. When the axial forceis removed from the seal member 26′″, the body portion 50′″ can expandas a result of the bias so as to return the seal member 26′″ to itsrelaxed state.

Additionally, as shown in FIG. 25A, a slit or opening 52′″ can be formedin the proximal end portion 34′″ of the seal member 26′″. The sealmember 26 can be configured so that the slit 52′″ is biased to a closedposition, so as to substantially prevent or inhibit any liquid fromflowing through the slit 52′″ or the opening 54′″ formed in the sealmember 26′″. Additionally, as will be described in greater detail below,the slit 52′″ can be opened by retracting the seal member 26′″ in thedistal direction over the support member 28, causing at least a portionof the proximal end portion of the support member 28 to penetrate andpass through the slit 52′″.

FIG. 26A is a perspective view of another embodiment of a support member28″″ that can be used with the connector 20 shown in FIG. 2A or anyother connector disclosed herein. FIG. 26B is a section view of theembodiment of the support member 28″″ shown in FIG. 26A, taken throughthe axial centerline of the support member 28″″. FIG. 26C is a sectionview of a connector 20 comprising the support member 28″″. In someembodiments, the support member 28″″ can have any of the feature orother details or configurations of the support member 28. Additionally,the support member 28″″ can be configured to operate with the bodymember 22, the base member 24, the seal member 26, the regulator 30, andtheir components described herein. Thus, in some embodiments, thesupport member 28″″ can be interchangeable with the support member 28.Many features of the support member 28″″ illustrated in FIG. 26A-26B canbe the same as or similar to the corresponding features of the supportmember 28.

As illustrated in FIGS. 26A-26C, the support member 28″″ can include afluid diverter 65′″ configured to divert at least a portion of theflowing fluid out of the fluid passageway 69″″, through the openings86″″ formed in the distal portion 64″″ of the support member 28″″, andinto the chamber or chambers 88″″ formed between the support member 28″″and the body portion 100 of the regulator 30.

In some embodiments, the fluid diverter can be a ball 65″″. The ball65″″ can be formed from a generally rigid material such as nylon, or asemi-rigid or flexible material. In some embodiments, the ball 65″″ canbe lodged in the fluid passageway 69″″ at a position such that a portionof the openings 86″″ is located proximal to the ball 65″″ and a portionof the openings 86″″ is located distal to the ball 65″″, as shown inFIG. 26B. In some embodiments, the ball 65″″ can be formed separatelyfrom the remainder of the support member 28″″ (as shown in FIG. 26A),and can be inserted into the fluid passageway, for example, through theopening 66″″. In some embodiments, the ball 65″″ can be formed from amore rigid material than the distal end portion 64″″ of the supportmember 28″″ such that the walls of the opening 66″″ and of the fluidpassageway 69″″ can temporarily flex outwardly by a small amount as theball 65″″ is inserted therethrough. In some embodiments, the ball 65″″can be formed from a less rigid material than the distal end portion64″″ of the support member 28″″ such that the ball 65″″ can compress anddeform as it is inserted through the opening 66″″ and up through thefluid passageway 69″″. In some embodiments, the walls of the opening66″″ and of the fluid passageway 69″″ can expand while the ballsimultaneously compresses and deforms during insertion. In someembodiments, the ball 65″″ can be formed from the same material (e.g.,polycarbonate) as the rest of the support member 28″″.

In some embodiments, the ball 65″″ can have a diameter larger than thefluid passageway 69″″, such that the ball 65″″ can be secured in placeduring operation by the friction generated by the walls of the fluidpassageway 69″″ pressing against the outer surface of the ball 65″″.Depending on the materials selected, the ball 65″″ and/or the walls ofthe fluid passageway 69″″ can be compressed or flexed or otherwiseconfigured to maintain a friction fit to hold the ball 65″″ in place. Insome embodiments, the fluid passageway 69″″ can include a groove 67″″configured to receive the ball 65″″. The groove 67″″ can be, forexample, shaped similar to at least a portion of the surface of the ball65″″ and can have a diameter that is equal to or slightly smaller thanthe ball 65″″. The ball 65″″ can be generally maintained in place onceit has been inserted to the point where it “snaps” into the groove 67″″.The fluid diverter 65″″ can have a smooth, rounded, curved, and/orgradually changing shape configured to substantially avoid or diminishabrupt, angular shifts in the fluid flow and accompanying turbulencetherein and/or damage to the transported fluid (especially blood cells).

As can be seen in FIG. 26C, during operation, fluid can flow from asyringe or other medical implement connected to the proximal end 162 ofthe body portion 22 of the connector 20 into the fluid passageway 69″″of the support member 28″″ via one or more openings 68″″ in the elongateportion 62″″. The fluid can flow distally through the fluid passageway69″″ until it reaches the fluid diverter (e.g., the ball 65″″). Thefluid diverter can cause the fluid to flow out of the fluid passageway69″″ and into the one or more chambers 88″″ via the openings 86″″. Thefluid can reenter the fluid passageway 69″″ via the openings 86″″ at alocation distal to the fluid diverter. The fluid can then flow out ofthe support member 28″″ via the opening 66″″ and through the slits 110of the regulator 30 and out the distal end of the base member 24. Thus,the fluid diverter can interrupt the substantially linear or laminarflow path of fluid between the proximal and distal ends that canotherwise occur inside of the support member 28″″ and can increase thelateral fluid flow through the chamber or chambers 88″″, therebypreventing or diminishing fluid stagnation in the chamber or chambers88″″. In some embodiments, the increased fluid flow through the chamberor chambers 88″″ can prevent or diminish the risk of clotting (in theevent that blood is transported through the connector 20), bacteriadevelopment, or other adverse affects that can result from stagnantfluid inside the connector 20. It will be understood that although theoperation of the connector 20 with the support member 28″″ was describedabove with respect to fluid flowing from the proximal end to the distalend of the connector 20, the fluid diverter can also divert fluid intothe chamber or chambers 88″″ to increase fluid flow therein if fluid isdrawn from the distal to proximal ends of the connector 20 (e.g., whendrawing blood from a patient into the syringe 120). A fluid diverter canalso be used independent of a support member, such as when no supportmember is present, in which case some embodiments can include a diverterthat is attached to or configured to move within the housing or anotherstructure.

It will be understood that although the fluid diverter is shown in FIGS.26A-26C as being a ball 65″″ having a substantially spherical shape,many other shapes of fluid diverters can be inserted into the fluidpassageway 69″″ to direct fluid into the chamber or chambers 88″″, suchas a substantially flat plate, a pyramid, diamond, or teardrop-shapedinsert, etc. Many variations are possible.

FIG. 26D is a section view of another embodiment of a support member28″″. In some embodiments, the support member 28′″″ can have any of thefeature or other details or configurations of the support member 28.Additionally, the support member 28′″″ can be configured to operate withthe body member 22, the base member 24, the seal member 26, or theregulator 30 with little or no modification to those components. Thus,in some embodiments, the support member 28′″″ can be interchangeablewith the support member 28 with little or no modification to the othercomponents of comprising the connector 20. Many features of the supportmember 28′″″ illustrated in FIG. 26D can be the same as or similar tothe corresponding features of the support member 28.

In some embodiments, the support member 28′″″ can include a flowdiverter 65″″ that is integrally formed as part of the support member28″″. In some embodiments, the flow diverter 65′″″ can be injectionmolded as part of the distal portion 64′″″ of the support member 28′″″.The flow diverter 65′″″ can be positioned in the fluid passageway 69′″″such that a portion of the openings 86′″″ are positioned proximal to thefluid diverter 65′″″ and a portion of the openings 86′″″ are positioneddistal to the fluid diverter 65′″″. Thus, the fluid diverter 65′″″ canoperate in a manner similar to the ball 65″″, directing fluid out if thefluid passageway 69′″″ and into the chamber or chambers 88′″″ and thenfrom the chamber or chambers 88′″″ back into the fluid passageway 69′″″via the openings 86′″″. In some embodiments, as illustrated, the flowdiverter can be narrower on its proximal and/or distal ends (where itinitially contacts the flowing fluid, depending on the flow direction)than in its intermediate region to assist in more gradually changing thedirection of at least a portion of the flowing fluid from a generallyvertical flow direction to an increased lateral flow direction. Theincreased flow of fluid through the chamber or chambers 88′″″ caused bythe fluid diverter 65′″″ can prevent fluid stagnation in the chamber orchambers 88′″″. In some embodiments, the fluid diverter 65′″″ can be asubstantially diamond-shaped piece having rounded corners to divide theflow of fluid without abrupt turns.

FIGS. 27 and 28 are perspective views of another embodiment of a valveor needleless connector 220. FIGS. 29 and 30 are exploded views of theembodiment of the connector 220 shown in FIG. 27. In some embodiments,the connector 220 can have any of the features or other details orconfigurations of any other connector described herein, including butnot limited to connector 20.

Some embodiments of the connector 220 can be formed so that there isvery little dead space volume within the connector 220 as compared tothe volume range of a typical bolus of fluid administered to a targetpatient population. Thus, the volume of fluid entering into theconnector 220 can be substantially equivalent to the volume of fluidleaving the connector 220. Further, the total equivalent fluid volume ofthe connector 220 can be very small such that the volume of fluidflowing through the system in order to place the valve in fluidcommunication with a medical implement such as a syringe can be veryclose or equal to zero. Even in embodiments including an internal valvemechanism, such as the embodiment illustrated in FIGS. 1-6, the valvemechanism can be configured to achieve the negative flow compensationeffects while reducing dead space.

As will be described, the body member 222 and the base member 224 can bejoined together to provide a rigid housing that substantiallyencapsulates the seal member 226. The body member 222 and the basemember 224 can be joined together using any suitable method or features,including but not limited to the features described elsewhere herein forjoining the body member 22 with the base member 24.

With reference to FIGS. 27-30, in some embodiments, the connector 220can comprise a body member 222, a base member 224, and a seal member226. In some embodiments, the body member 222 and the seal member 226can be the same or similar to the embodiments of the body member 22 andthe seal member 26 or any other body member or seal member describedherein. As illustrated, the seal member 226 can be configured such thatthe proximal end portion 234 of the seal number 226 can be sealinglyreceived by an opening 236 formed in the body member 222. In someembodiments, as in the illustrated embodiment, the proximal end portion234 of the seal member 226 can have a lip portion 238 (which can be anannular protrusion) formed thereon that is configured to contact theinside surface of the opening 236 of the body member 222 to provide aseal therewith.

The seal member 226 can also comprise an annular collar portion 242,similarly configured as compared to the collar portion 42′ of the sealmember 26′. In some embodiments, the collar portion 242 can beconfigured to interact with an inside surface of the body member 222(which can be an annular protrusion, one or more tabs, or otherprotruding feature) so as to limit the axial movement of the proximalend portion 234 of the seal member 226 in the proximal direction. Insome embodiments, the body member 222 and the seal member 226 can beconfigured so that the end surface 246 (which can be planar) of the sealmember 226 can be adjacent to or approximately coplanar with the endsurface 248 of the body member 222, when the seal member 226 is in theclosed position. The closed position of the seal member 226 isillustrated in FIG. 27. The seal member 226 and body member 222 can thusbe configured so that the end surface 246 can be consistently alignedwith the end surface 248 of the body member 222 when the seal member 226is in the closed position as described in connection with otherembodiments herein.

The seal member 226 can have a resilient body portion 250 having aplurality of accordion-like structures configured to permit the sealmember 226 to resiliently compress and expand as axial forces areapplied to the proximal end portion 234 of the seal member 226. The bodyportion 250 can have a generally consistent cross-sectional shapethroughout the length thereof (as illustrated), or the cross-section ofthe body portion 250 can vary along at least a portion of the lengththereof, such as with the body portion 50′ of the seal member 26′. Theseal member 226 can have any of features, sizes, or other configurationdetails of any other seal member disclosed herein.

Additionally, as shown in FIG. 29, a slit or opening 252 can be formedin the proximal end portion 234 of the seal member 226. The seal member226 can be configured so that the slit 252 is biased to a closedposition, so as to substantially prevent or inhibit any liquid fromflowing through the slit 252 or the opening 254 formed in the sealmember 226. The opening 254 can be configured such that the elongatedportion 262 can be received therein. Additionally, as will be describedin greater detail below, the slit 252 can be opened by retracting theseal member 226 in the distal direction over the elongated portion 262,causing at least a portion of the proximal end portion of the elongatedportion 262 to penetrate and pass through the slit 252.

With reference to FIG. 29, the elongated portion 262 can project fromthe base member 224. In some embodiments, the elongated portion 262 canhave the same features or configurations of any of the other elongatedportions described herein, including but not limited to the elongatedportion 62. As illustrated, the elongated portion 262 can have one ormore openings 268 therethrough. Additionally, the elongated portion 262can have a tapered (or cylindrical) outer surface 270 and a proximal tipportion 272. The proximal tip portion 272 can have a tapered outersurface, or can be generally cylindrical.

The proximal tip portion 272 can be configured so that the proximal endportion 234 of the seal member 226 in some embodiments can be retractedrelative to the proximal tip portion 272 of the elongated portion 262without significant drag or resistance from the elongated portion 262.In some embodiments, the proximal tip portion 272 can have a sharp orrounded tip 274 configured to penetrate through the slit 252 formed inthe seal member 226.

The base member 224 can have a male tip protrusion 241 projectingtherefrom, the male tip protrusion 241 defining an opening 237therethrough that can be in fluid communication with the passageway 269extending axially through the elongated portion 262 and the one or moreopenings 268 formed in the elongated portion 262. Additionally, a shroud243 having protrusions 245 or other features designed to enhance thegrip of the connector 220 thereon and internal threads 247 formed on theinside surface of the shroud 243. The base member 224 can be configuredto conform with ANSI standards for medical connectors.

FIG. 31 is a section view of the embodiment of the connector 220 shownin FIG. 27, showing the seal member 226 in a first or closed positionbefore the seal member 226 has been contacted and opened by the syringe120. FIG. 32 is a section view of the embodiment of the connector 220shown in FIG. 27, showing the seal member 226 in a second or openposition after the seal member 226 has been contacted and opened by thesyringe 120.

The syringe 120 illustrated in FIGS. 31 and 32 (and elsewhere in thisdisclosure) is an example of one type of medical implements that can beused with the connector 220. However, the connector 220 can beconfigured for use with a wide range of medical implements and is notlimited to use with the syringe 120. The syringe 120 can be any suitableor common syringe used in the medical field.

With reference to FIG. 31, the body member 222 can have an annular ridgeor protrusion 260 formed around an outside surface 222 a of the bodymember 222 adjacent to a proximal end portion 263 of the body member222. The proximal end portion 263 can be smooth and generallycylindrical, or can have external threads or thread features formedthereon so that the connector 220 can be threadedly joined with othersuitable medical implements. The inside surface 222 b of the body member222 can be generally smooth (as illustrated in FIGS. 31 and 32). In someembodiments, the inside surface 222 b of the body member 222 can includegenerally axially oriented, generally linearly arranged ridges orchannels, or other such features configured to receive portions of theseal member 226 as the seal member 226 is compressed and expandedoutwardly against such ridges or channels when the seal member 226 isopened.

Additionally, the body member 222 can include an inside abutment surface264 that can be configured to interact with the corresponding annularcollar portion 242 formed on the seal member 226. The abutment surface264 and annular collar portion 242 formed on the body member 222 and theseal member 226, respectively, can be configured to limit the motion ofthe seal member 226 relative to the body member 222 in the proximaldirection (e.g., the direction represented by arrow A6 shown in FIG.32). In some embodiments, the abutment surface 264 and the annularcollar portion 242 formed on the body member 222 and the seal member226, respectively, can be configured to stop the seal member 226 at theapproximate position where the end surface 246 of the seal member 226can be generally adjacent to or approximately coplanar with the endsurface 248 of the body member 222 so that the end surface 246 of theseal member 226 cannot protrude past a certain point, such as the regionat or near the end surface 248 of the body member 222.

Similar to the base member 24, as illustrated in FIGS. 29 and 30, thebase member 224 can include a proximal end portion 267 having one ormore protrusions 271 positioned around an outside surface of theproximal end portion 267 of the base member 224. Additionally, the bodymember 222 can comprise a distal end portion 275 defining an opening 277extending through the entire body member 222, and one or more channelsor notches 279 formed in the distal end portion 275 of the body member222. The one or more channels or notches 275 can be configured toreceive the one or more protrusions 271 formed on the proximal endportion 267 of the base member 224. The protrusions 271 and the notches275 can be configured to substantially prevent the body member 222 fromrotating relative to the base member 224, thereby providing a moresecure joint between the body member 222 and the base member 224.

As shown in FIGS. 31 and 32, the body portion 250 of the seal member 226can extend into the base member 224. The force with which a resilientseal member rebounds to the first or closed position is determined by anumber of factors, including the resiliency of the material, the shapeof the seal member walls, and the length of the seal member. In someembodiments, the increased length of the body portion 250 of the sealmember 226 as compared to certain other seal members disclosed hereincan reduce the force with which the seal member 226 returns to the firstposition upon withdrawal of a syringe or other medical implement, makingit easier to disconnect and connect the medical implements. In someembodiments, the body portion 250 in a relaxed state is betweenapproximately 1 and approximately 4 times as long as the proximalportion 234 (including any annular projection) of the seal member 226.In some embodiments, the body portion 250 is between approximately 1.5and approximately 3 times as long as the proximal portion 234 of theseal member 226. In some embodiments, the body portion 250 isapproximately at least 2.5 times as long as the proximal portion 234 ofthe seal member 226.

The operation of the connector 220 will now be described. FIG. 31illustrates the position of the components comprising the connector 220when the seal member 226 is in the closed position (e.g., before asyringe or other medical implement has been joined with the connector220). In this configuration, the seal member 226 can be biased to theclosed position, as illustrated in FIG. 31.

FIG. 32 illustrates the seal member 226 in an open position in responseto the insertion of the syringe 120 being joined with the connector 220.As illustrated in FIG. 32, the cannula 126 of the syringe 120 has beenpushed in the direction represented by arrow A7 in FIG. 32 against theseal member 226 with sufficient force to overcome the bias of the sealmember 226 so as to cause the seal member 226 to compress within thebody member 222. When the seal member 226 has been compressed within thebody member 222 to a sufficient distance such that the end surface 246of the seal member 226 has passed the openings 268 formed in the supportmember, 228, the passageway 269 will be in fluid communication with theinside of the syringe 120. The force that the cannula 126 exerts on theend surface 246 of the seal member 226 can be sufficient to cause asubstantially fluid-tight seal between the cannula 126 and the endsurface 246 of the seal member 226, so that all or substantially all ofthe fluid within and/or leaving the syringe 120 is caused to flow intothe passageway 269 when the syringe 120 is so joined with the connector220.

Thus, when the seal member 226 is in the open position, as illustratedin FIG. 32, the plunger 128 of the syringe 120 can be depressed so as toforce fluid into the connector 220. Flow arrows in FIG. 32 illustratethat, when fluid is forced from the syringe 120, fluid can flow into theopening or openings 268 formed in the support member 228, through thepassageway 269 formed in the support member 228, through the opening 237formed in the base member 224, and into any other medical implement, ifany, joined with the base member 224. As discussed, when the syringe 120or other medical implement is removed from connector 220, the connector220 can be configured such that the seal member 226 can return to theclosed position due to the bias force within the seal member 226.

In the illustrated embodiment, the connector 220 does not include abackflow prevention module but the connector 220 can be configured toinclude a backflow resistance module, which can be the same as orsimilar to the backflow resistance module in connection with theconnector 20. For example, the connector 220 can include a variablevolume chamber and a valve configured to resist backflow of fluid. Insome embodiments, the backflow resistance module can include a regulatorsimilar to the regulator 30.

FIG. 33 is a distal exploded view of another valve or needlelessconnector 320. FIG. 34 is a exploded section view of connector 320 shownin FIG. 33, taken along the axial centerline of the connector 320. Insome embodiments, the connector 320 can have any of the features orother details or configurations of any other connector described herein,including but not limited to connector 20.

With reference to FIGS. 33 and 34, in some embodiments, the connector320 can comprise a body member 322, a base member 324, a seal member326, support member 328, and regulator 330, which can be the same as orsimilar to the body member 22, base member 24, seal member 26, supportmember 28, and regulator 30 or any other of such components describedherein. The body member 322 and base member 324 can be coupled togetherto form a rigid housing that generally encapsulates the seal member 326,the support member 328, and the regulator 330. The body member 322 canbe coupled to the base member 324 using an adhesive, snaps, sonicwelding, or any other suitable method of feature, including but notlimited to the method and features described herein.

In the illustrated embodiment, the seal 326 can be configured such thatthe proximal end region 334 thereof can be received by an opening 336formed in the body member 322. The fitting between the proximal endregion 334 and the opening 336 can produce a substantially fluid-tightseal. In some embodiments, the proximal end portion 334 of the sealmember 326 can have a lip portion 338 (which can be an annularprotrusion) formed thereon that is configured to contact the insidesurface of the opening 336 of the body member 322 to provide a movingseal therewith.

The seal member 326 can also have an annular collar portion 342, whichcan be similar to the collar portion 42′ of the seal member 26′. In someembodiments, the collar portion 342 can be spaced distally from theproximal end portion 334 and can be larger in diameter than any otherportion of the proximal end portion 334 or any other portion of the sealmember 326. The collar portion 342 can be configured to interact with aninside surface of the body member 322 (which can be an annularprotrusion, one or more tabs, or other protruding feature) so as tolimit the axial movement of the proximal end portion 334 of the sealmember 326 in the proximal direction. In some embodiments, the verticalthickness of the collar portion 342 can be at least as large as, orsubstantially larger than, the thickness of the wall of the seal member326 in other nearby or adjacent regions, as illustrated, to diminishbending or contortion of the collar portion 342. In some embodiments,the body member 322 and the seal member 326 can be configured so thatthe end surface 346 (which can be planar) of the seal member 326 can beadjacent to or approximately coplanar with the end surface 348 of thebody member 322, when the seal member 326 is in the closed position. Theseal member 326 and body member 322 can thus be configured so that theend surface 346 can be consistently aligned generally with the endsurface 348 of the body member 322 when the seal member 326 is in theclosed position.

The seal member 326 can have a resilient body portion 350 having aplurality, of stiffer segments, regions, or o-rings 351 separated by oneor more resilient collapsible sections 349 configured to permit the sealmember 326 to resiliently compress and expand as axial forces areapplied to the proximal end portion 334 of the seal member 326. The bodyportion 350 can have a generally consistent cross-sectional shapethroughout the length thereof, or the cross-section of the body portion350 can vary along at least a portion of the length thereof (asillustrated). In some embodiments, as illustrated, the proximal regionof the seal member 326 can comprise a proximal end region 334 thatgenerally tapers radially inwardly in a downward or distal direction,and a distal region of the seal member 326 that can generally taperradially outwardly in a downward or distal direction. The seal member326 can have any of the features, sizes, or other configuration detailsof any other seal member disclosed herein.

The seal member 326 is illustrated in the open (e.g., compressed)position in FIG. 35. In an open and/or closed state, the seal member 326can have collapsible regions with walls that are less than aboutone-third or less than about one-quarter as thick as the walls of nearbystiffer regions. The collapsible sections 349 can be configured tobuckle radially outwardly away from the elongate portion 362 of thesupport member 328 when the seal member 326 is compressed. Thecollapsible sections 349 can be horizontally spaced from, and/orgenerally otherwise configured so that they do not slidingly contact,the elongate portion 362 when the seal member 326 is in the collapsed oropen state and/or as the seal member 326 progresses from the closed tothe open state. In some embodiments, at least one, some, or all of thestiffer regions, segments, or o-rings 351 are configured to contact theelongate portion 362 as the seal member 326 slides axially thereon. Insome embodiments, substantially less than half of the surface area ofthe inner surface of the seal member 326 contacts the elongate portion362 when the seal member 326 is in the open or compressed state, and/oras it progresses from the closed to the open state. In some embodiments,the inner surface of the collar portion 342 (e.g., inside of the seal)can be configured to bow radially outwardly when the seal member 326 iscompressed. In some embodiments, the proximal portion 334 of the sealmember 326 can also include one or more o-rings 351 and/or one or morecollapsible sections 349. In some embodiments, the o-rings 351 canprotrude radially inwardly so that the collapsible sections 349 and/orthe inner surface of the collar portion 342 do not contact the elongateportion 362 when the seal member 326 is in the closed state. The sealmember 326 is shown in the closed state, for example, in FIG. 34.

In the open position, as illustrated in FIG. 35, the seal member 326 caninclude at least one radially outwardly extending portion 349 on itsproximal side (for example, between the collar 342, if present, and theproximal end surface 346) that is larger in cross-sectional area (e.g.,defined by the outer perimeter) than the surface area of the proximalend portion 346. The seal member 326 can include at least a firstradially outwardly extending portion 353 on the distal side (forexample, between the collar 342, if present, and the distal end portion)that is larger in cross-sectional area than the collar 342 and/or thesurface area of the proximal end portion 346. The seal member 326 caninclude at least a second radially outwardly extending portion 355 onthe distal side that is larger in cross-sectional area than thecross-sectional area of nearby or contiguous portions of the collapsiblewall of seal member 326, and smaller in cross-sectional area than thefirst radially outwardly extending portion 353 on the distal side. Insome embodiments, the seal member 326 is free to slide axially on theelongate support member with relatively little frictional resistancebecause much of the inner surface of the seal member 326 does notcontact the elongate portion 362, Thus, the seal member 326 can beconfigured to reduce the likelihood that the seal member 326 will becomestuck in or move slowly away from the open (e.g., compressed) state.

The seal member 326 can be configured in a variety of other manners. Forexample, in the embodiment illustrated, the seal member 326 includes aplurality (e.g., four) of stiffer regions or segments, such as o-rings,and a plurality (e.g., three) of collapsible sections 349, but othernumbers of stiffer regions, segments, or o-rings 351 and/or collapsiblesections 349 can be used. Also, in some embodiments, the collapsiblesections 349 can be configured to collapse radially inwardly so that aportion of the collapsible sections 349 contacts the elongate portion362 while other portions of the inner surface of the seal member 326 aremaintained out of contact with the elongate portion 362.

A slit or opening 352 can be formed in the proximal end portion 334 ofthe seal member 326. The seal member 326 can be configured so that theslit 352 is biased to a closed position, so as to substantially preventor inhibit any liquid from flowing through the slit 352 or the opening354 formed in the seal member 326. The opening 354 can be configuredsuch that the elongated portion 362 can be received therein. The slit352 can be opened by retracting the seal member 326 in the distaldirection over the elongated portion 362, causing at least a portion ofthe proximal end portion of the elongated portion 362 to penetrate andpass through the slit 352.

The support member 328 can be the same as or similar to the supportmember 28, and can include, for example, an elongate portion 362projecting from a base portion 360 in the proximal direction, and adistal portion 364 projection from the base portion 360 in the distaldirection. The distal portion 364 can include an opening 366 that can bein fluid communication with a fluid passageway 369 extending axiallythrough the distal portion 364, the base portion 360 and at least aportion of the elongate portion 362. The elongate portion 362 caninclude one or more openings 368 in fluid communication with the fluidpassageway 369 and the opening 366. The distal portion 364 can includeone or more openings 386 in fluid communication with the fluidpassageway 369. The support member 328 can have any of features, sizes,or other configuration details of any other support member disclosedherein.

The regulator 330 can be the same as or similar to the regulator 30, andcan include, for example, a cylindrical body portion 300, an annularraised proximal portion 302, and a distal end portion 308. The distalend portion 308 can be substantially dome shaped or hemisphericallyshaped. The distal end portion 308 can have one or more slits 310 formedtherein. In some embodiments, the slits 310 can be biased to a closedstate, but can open to allow fluid to flow through the regulator 330 ifa sufficient pressure differential is applied, as discussed elsewhereherein.

The base member 324 can have a male tip protrusion 341 projectingtherefrom, the male tip protrusion 341 defining an opening 337therethrough that can be in fluid communication with the passageway 369extending axially through the support member 328 and the one or moreopenings 368 formed in the elongated portion 362. The base member 324can also include a shroud 343 having internal threads formed on theinside surface thereof. The base member can include one or moreprotrusions 371 positioned around an outside surface of the proximal endportion 367 of the base member 324. Additionally, the body member 322can have one or more channels or notches 377 formed in the distal endportion 375 thereof. The one or more channels or notches 377 can beconfigured to receive the one or more protrusions 371 to substantiallyprevent the body member 322 from rotating relative to the base member324. Additionally, the body member 322 can comprise an annular channel383 configured to receive an annular protrusion 381 formed on theproximal end portion 367 of the base member 324 to provide a snap-fittype connection between the body member 322 and the base member 324.

The body member 322 can have an annular ridge or protrusion 359 formedaround an outside surface of the body member 322 adjacent to a proximalend portion 363 of the body member 322. The proximal end portion 363 canbe smooth and generally cylindrical, or can have external threads orthread features formed thereon so that the connector 320 can bethreadedly joined with other suitable medical implements. Additionally,the body member 322 can comprise an inside abutment surface 365 that canbe configured to interact with the corresponding annular collar portion342 formed on the seal member 326. The abutment surface 36 and annularcollar portion 342 formed on the body member 322 and the seal member326, respectively, can be configured to limit the motion of the sealmember 326 relative to the body member 322 in the proximal direction. Insome embodiments, the abutment surface 364 and the annular collarportion 342 formed on the body member 322 and the seal member 326,respectively, can be configured to stop the seal member 326 at theapproximate position where the end surface 346 of the seal member 326can be generally adjacent to or approximately coplanar with the endsurface 348 of the body member 322 so that the end surface 346 of theseal member 326 cannot protrude past a certain point, such as the regionat or near the end surface 348 of the body member 322, or so that theend surface 346 of the seal member 326 cannot protrude past the endsurface 348 of the body member 322 by more than a predetermined amount(e.g., at least about 1 mm).

FIGS. 36 and 37 are perspective views of an embodiment of a valve orneedleless connector 420. FIGS. 38 and 39 are exploded perspective viewsof the connector 420. FIG. 40 is an exploded sectional view of theconnector 420. In some embodiments, the connector 420 can have any ofthe features or other details or configurations of any other connectordescribed herein including but not limited to the connector 20. Theconnector 420 can be especially suited for use as an intermediateconnector in a fluid flow path between two portions of a patient fluidline or catheter, although may other uses are also possible, asillustrated herein.

Referring to FIGS. 36-40, in the illustrated embodiment, the connector420 can include a body member 422, a base member 424, a support member428, and a regulator 430, which can be the same as, or similar to, thebody member 22, base member 24, support member 28, and regulator 30 inconnection with the connector 20. In some embodiments, the connector 420can include a backflow resistance module, while omitting some of theother features of the connector 20. Notably, the illustrated embodimentcan be formed without the seal member. As will be discussed in greaterdetail below, in some embodiments, the connector 420 can be configuredto attach to a connector that does not include backflow prevention(e.g., the illustrated embodiment of connectors 220) to add backflowprevention functionality to the connector. In some embodiments, theconnector 420 can be configured to be used directly with a medicalimplement (e.g., syringe 120).

The body member 422 can be coupled to the base member 424 to form ahousing that generally encapsulates the support member 428 and regulator430. The body member 422 can be coupled to the base member 424 using anadhesive, snaps, sonic welding, or any other suitable method of feature,including but not limited to the method and features described herein.

The support member 428 can be the same as or similar to any of thesupport members disclosed herein and can include, for example, a baseportion 460, and a distal portion 464 projecting from the base portion460 in the distal direction. The distal portion 464 can include anopening 466 that can be in fluid communication with a fluid passageway469 extending axially through the distal portion 364 and the baseportion 460. The base portion 460 can include an opening 468 in fluidcommunication with the fluid passageway 469 and the opening 466. Thedistal portion 464 can include one or more openings 486 in fluidcommunication with the fluid passageway 469. In some embodiments, asillustrated, the support member 428 can be formed without the elongateportion.

The regulator 430 can be the same as or similar to any of the otherregulators, valves, or valve members or components thereof disclosedherein. The regulator 430 can include, for example, a cylindrical bodyportion 400, an annular raised proximal portion 402, and a distal endportion 408. The distal end portion 408 can be substantially dome shapedor hemispherically shaped. The distal end portion 408 can have one ormore slits 410 formed therein. In some embodiments, the slits 410 can bebiased to a closed state, but can open to allow fluid to flow throughthe regulator 430 if a sufficient pressure differential is applied.

The base member 424 can have a male tip protrusion 441 projectingtherefrom, the male tip protrusion 441 defining an opening 437therethrough that can be in fluid communication with the passageway 469extending axially through the support member 428. The base member 424can also include a shroud 443 having internal threads formed on theinside surface thereof. The base member 424 can include one or moreprotrusions 471 positioned around an outside surface of the proximal endportion 467 of the base member 424. Additionally, the body member 422can have one or more channels or notches 477 formed in the distal endportion 475 thereof. The one or more channels or notches 477 can beconfigured to receive the one or more protrusions 471 to substantiallyprevent the body member 422 from rotating relative to the base member424. Additionally, the body member 422 can include an annular channel483 configured to receive an annular protrusion 481 formed on theproximal end portion 467 of the base member 424 to provide a snap-fittype connection between the body member 422 and the base member 424.

The body member 422 can have a proximal end portion 463 which can besmooth and generally cylindrical, or can have external threads or threadfeatures formed thereon so that the connector 420 can be threadedlyjoined with other suitable medical implements such as, for example, aconnector that lacks backflow prevention functionality (e.g., theillustrated embodiment of connector 220). An opening 436 can be formedin the proximal end portion 463 of the body member 422. In someembodiments, the connector 420 can be formed without a seal memberconfigured to close the opening 436.

In some embodiments, the connector 420 can also include a cap 491. Thecap can include a closed male protrusion 493, and a shroud 495surrounding the closed male protrusion 493. The shroud 495 can haveinternal threads formed on the inside surface thereof configured tothreadedly mate with the external threads on the proximal end portion463 of the body member 422. The cap 491 can include gripping features497 formed on the outside surface of the shroud 495 to facilitatesecuring or removal of the cap 491. Many variations are possible. Forexample, in some embodiments, the cap 491 can be formed without theclosed male protrusion 493.

FIG. 41 is a sectional view of the connector 420 and a connector 520without backflow prevention functionality 520 in an unengagedconfiguration. FIG. 42 is a sectional view of the connector 420 and theconnector 520 in an engaged configuration. With reference now to FIGS.41 and 42, the cap 491 can be configured to seal the opening 436 whensecured to the proximal end 463 of the body member 422, as shown in FIG.41. In some embodiments, some portion of the cap (such as closed maleprotrusion 493, the annular surface 499 surrounding the base of theclosed male protrusion 493), can include a seal (e.g., an o-ring)configured to seal against the end surface 448, or other portion, of thebody member 422. In some embodiments, the closed male protrusion 493 canextend into the opening 436, and can be configured to seal against theinside surface of the body member 422.

The connector 520 can be, for example, a version of the Clave® connectormanufactured by ICU Medical, Inc., of San Clemente, Calif. Variousembodiments of a connector of this type are described in U.S. Pat. No.5,685,866 (the “'866 patent”), the entirety of which is incorporatedherein by reference. The connector 520 can include for example, a bodymember 522, a base member 524, and a seal member 526. The body member522 can be coupled to the base member 524 to form a housing. The basemember 524 can include a male tip protrusion 541 and an elongate portion562. A fluid passageway 569 can extend through the male tip protrusion541 and through at least a portion of the elongate portion 562 to one ormore holes 568 formed near the proximal end of the elongate portion 562.The body member 522 can include a shroud 543 configured to surround themale tip protrusion when the body member 522 and base member 524 arecoupled to each another. The shroud can have internal threads formed onthe inside surface thereof configured to mate with the external threadsformed on the proximal end portion 463 of the connector 420. The bodymember 522 can also include a proximal end 563 that can include externalthreads so that the connector 520 can be threadedly joined with othersuitable medical implements (e.g., a syringe).

The seal member 526 can be positioned so that it surrounds at least aportion of the elongate portion 562. The seal member 526 can be the sameas or similar to the seal member 26 or any other seal member describedherein. In some embodiments, the seal member 562 can be configured toresiliently compress when a medical implement is attached to theproximal end 563 of the connector 520, exposing the one or more holes568 on the elongate portion 562 and opening a fluid connection betweenthe fluid passageway 569 and the medical implement.

In some embodiments, the connector 520 does not include backflowprevention functionality, such that if the connector 520 where usedwithout having the connector 420 attached thereto, the connector 520 mayexperience a degree of fluid backflow upon the occurrence of a syringerebound, medical implement disconnect, or other backflow inducing event.The connector 420 can include a backflow resistance module, which can bemade up of various components of the connector 420 such as the regulator430, the support member 428, etc. Under some circumstances, theconnector 420 can be coupled to the connector 520 (as shown in FIG. 42)to add backflow prevention functionality to the connector 520. Thus,when the connector 520 is coupled to the connector 420, the backflowresistance module can function substantially as described elsewhereherein to prevent fluid backflow out of the connector 520 in the eventof a syringe rebound, or other backflow inducing event. It will beunderstood that the connector 520 can be any of a variety of otherconnector types. Thus, the connector 420 can be used to add backflowprevention functionality to a variety of connector types that provide avariety of different features.

Under some circumstances, the connector 420 can remain coupled to theconnector 520 throughout the period of use of the connector 520, suchthat, once connected, the connectors 420 and 520 can be treated as asingle connector. In some embodiments, the connector 420 can be coupledto the connector 520 prior to being packaged or sold to the user. Insome embodiments, the connector 420 can be permanently coupled to theconnector 520 (e.g., using plastic welding or the like) prior to beingpackaged or sold to the user. In some embodiments, the connector 420 canbe used without the cap 491. For example, if the connector 420 is soldpre-attached to the connector 520, no cap 491 is used. Also, theconnector 420 without a cap 491 can be enclosed in sterile packagingdesigned to be opened immediately prior to connecting the connector 420to the connector 520.

Under some circumstances, a medical implement such as a syringe can beconnected directly to the proximal end portion 463 of the connector 420without the connector 520 being positioned therebetween. However, insome embodiments, the connector 420 does not include a resilient sealmember (e.g., the seal member 526) to reseal the opening 436 each timethe medical implement is removed. Thus, the use of the connector 420without the connector 520 attached thereto can be advantageous, forexample, in circumstances when the medical implement is to be connectedto the connector 420 only once, or a relatively few number of times. Insome embodiments, the cap 491 can be used to seal the proximal endportion 463 after the medical implement has been removed. In someembodiments, a fresh, sterilized cap can be used.

FIG. 43 is a perspective view of an embodiment of a regulator 630. FIG.44 is a section view of the regulator 630 shown in FIG. 43 taken throughthe axial centerline of the regulator 630. The regulator 630 can includea body portion 600, which can be, for example, substantiallycylindrical. The proximal end portion 602 of the regulator 630 caninclude an annular raised lip 603 and an opening 604 therethrough. Thedistal end portion 608 can include an inner annular protrusion 612 andan opening formed therethrough. In some embodiments, as illustrated, theregulator 630 can be formed without a closure portion (such as thedistal end portion 108 and slits 110 in connection with the regulator30). Thus, in some embodiments a fluid passageway is constantly openthrough the regulator 630.

FIG. 45 is a sectional view of a valve or needleless connector 620configured to use the regulator 630 shown in FIG. 43. In someembodiments, the connector 620 can have any of the features or otherdetails or configurations of any other connector described herein. Insome embodiments, the connector 620 can include a body member 622, abase member 624, a seal member 626, a support member 628, and theregulator 630, which can be, for example, the same as, or similar to,the body member 22, base member 24, seal member 26, support member 28,and regulator 30 in connection with the connector 20.

The regulator 630 can be positioned over the distal portion 664 of thesupport member 628, defining an annular cavity 688 between two annularprotrusions 690, 692 on the support member 628. The inner annularprotrusion 612 can be received within the channel 696 formed between theannular protrusions 690, 694 to secure the regulator 630 to the supportmember 628. In some embodiments, as illustrated, the regulator is inconstant fluid communication with the distal end of the fluid pathinside the valve.

The regulator 630, or at least a portion thereof, can be formed fromone, or a combination, of various suitable materials including, but notlimited to, rubber, silicone-based deformable materials, and the like,such that the body portion 600 of the regulator 630 can deflectinwardly, reducing the volume of the annular cavity 688 to compensatefor a syringe rebound or other backflow inducing event. In someembodiments, the regulator 630 can be configured such that less force isrequired to deflect the body portion 600 of the regulator 630 inwardlyto reduce the volume of the annular cavity 688 than to draw a similarvolume of fluid from the patient toward the connector 620 (e.g., againstgravity). Thus, if a syringe rebound, or other backflow inducing event,occurs, the body portion 600 of the regulator 630 can collapse, reducingthe volume of the annular cavity 688 and expelling fluid to compensatefor the vacuum and prevent or delay backflow.

FIG. 46 is a perspective view of an example of a valve member 730. FIG.47 is a section view of the valve member 730 shown in FIG. 46. The valvemember 730 can include a proximal end portion 702 that includes an innerannular protrusion 712 and an opening therethrough 704. The valve member730 can also include a distal end portion 708 that can be substantiallydome or hemispherically shaped, and can include one or more slits 710.Similarly to the regulator 30, the valve member 730 can be configured toremain closed and resist fluid flow until a pressure threshold isreached, at which point the slits 710 on the valve member 730 can opento allow fluid to flow therethrough. In some embodiments, the valvemember 730 can be configured such that greater force is required to openthe valve member 730 in a first direction (e.g., in the A2 direction)than in a second direction (e.g., in the A1 direction).

FIG. 48 is a section view of a valve or needleless connector 720configured to use the valve member 730 shown in FIG. 46. In someembodiments, the connector 720 can have any of the features or otherdetails or configurations of any other connector described herein. Insome embodiments, the connector 720 can include a body member 722, abase member 724, a seal member 726, a support member 728, and the valvemember 730, which can be, for example, the same as, or similar to, thebody member 22, base member 24, seal member 26, support member 28, andregulator 30 in connection with the connector 20.

The valve member 730 can be positioned over the distal portion 764 ofthe support member 728 so that the inner annular protrusion 712 isreceived within the channel 796 formed between the annular protrusions790, 794 to secure the valve member 730 to the support member 728.

In some embodiments as illustrated, the connector 720 can be formedwithout a variable volume chamber (e.g., the annular cavity 88). Inthese embodiments, because no variable volume chamber is present toalleviate the pressure caused by a syringe rebound, or other backflowinducing event, the valve member 730 may be configured to morerigorously resist backflow. For example, in some embodiments, thepressure of the fluid acting on the outside surface 708 b of the valvemember 730 can be between approximately 1.0 atmosphere and approximately2.0 atmospheres greater than the pressure of the fluid acting on theinside surface 708 a of the valve member 730 for the valve member 730 toopen in allow fluid flow in the A2 direction. The valve member 730 canbe modified in various ways to increase the threshold pressure requiredto open the valve member for fluid flow in the A2 direction. Forexample, the curvature, or thickness, or materials of the domed distalend portion 708 can be modified to adjust the backflow thresholdpressure. Also, the number or orientation of the slits 710 can bemodified to adjust the backflow threshold pressure.

FIG. 49 shows a section view of an embodiment of a valve or needlelessconnector 820 configured to use both the regulator 630 shown in FIG. 43and the valve member 730 shown in FIG. 46. In some embodiments, theconnector 820 can have any of the features or other details orconfigurations of any other connector described herein. In someembodiments, the connector 820 can include a body member 822, a basemember 824, a seal member 826, a support member 828, the regulator 630,and the valve member 730, which can be, for example, the same as, orsimilar to, the body member 22, base member 24, seal member 26, supportmember 28, and regulator 30 in connection with the connector 20.

In some embodiments, the support member 828 can include a first channel896 a formed between the annular protrusions 890, 894 a, and a secondchannel 896 b formed between the annular protrusions 894 a, 894 b. Whenassembled, the regulator 630 and valve member 730 can be positioned overthe distal portion 864 of the support member 828. The inner annularprotrusion 612 of the regulator 630 can be received within the channel896 a and the inner annular protrusion of the valve member 730 can bereceived within the channel 896 b, to prevent the regulator 630 and thevalve member 730 from moving axially with respect to the support member828. In some embodiments, the connector 820 can function similarly tothe connector 20, except that the variable volume chamber and backflowresist valve are provided by a separate regulator 630 and valve member730.

FIG. 50A is a section view of a base member 924. The base member 924 canbe similar in some regards to the base member 24. The base member 924can include a male tip protrusion 941 that includes an opening 937therethrough that can be in fluid communication with a cavity 921 formedin the base member 924. The cavity 921 can have an annular recess 923between an annular step 925 and an annular protrusion 927. A hole 929extending through the wall of the base member 924 can provide access tothe annular recess 923 so that air from outside the base member 924 canflow into and out of the annular recess 923 through the hole 929.

FIG. 50B shows a section view of an embodiment of a valve or needlelessconnector 920 that uses the base member 924 shown in FIG. 50A. In someembodiments, the connector 920 can have any of the features or otherdetails or configurations of any other connector described herein. Insome embodiments, the connector 920 can include a body member 922, thebase member 924, a seal member 926, a support member 928, and aregulator 930 which can be, for example, the same as, or similar to, thebody member 22, base member 24, seal member 26, support member 28, andregulator 30 in connection with the connector 20.

In some embodiments of the connector 920, the variable volume chambercan be configured to expand when fluid is infused from a medicalimplement (e.g., a syringe) into the connector 920. The variable volumechamber can be configured to return to its natural, unexpanded volume,or shrink to a volume that is less than its natural volume, tocompensate for syringe rebound, or other backflow inducing events, andprevent backflow.

The regulator 930 can be positioned over the distal portion 964 of thesupport member 928, defining an annular cavity 988 between the twoannular protrusions 990, 992 on the support member 928. The innerannular protrusion 912 of the regulator 930 can be received within thechannel 996 formed between the annular protrusions 990, 994 to securethe regulator 930 to the support member 928. The annular raised portion903 of the regulator 930 can be secured between the base portion 960 ofthe support member 928 and the top surface of the annular protrusion 927of the base member 924, sealing the top of the annular recess 923. Insome embodiments, the annular protrusion 90 can press the wall of theregulator 930 against the inside wall of the cavity 921 below theannular step 925 to form an airtight seal. Thus, air that enters theannular recess 923 through the hole 929 can be prevented from travelingto other parts of the connector 920 or from entering the fluid stream asa bubble, which can cause a serious health risk to the patient.

In some embodiments, the body portion 900 of the regulator 930 can beconfigured to flex outwardly into the annular recess 923, therebyincreasing the volume of the annular cavity 988, when pressure isapplied to the inside surface of the body portion 900, such as wheninfusing fluids from a medical implement (e.g., a syringe) into theconnector 920. In some embodiments, the force required to expand thevolume of the annular cavity 988 is less than the force required to openthe slits 910 on the regulator 930 to allow fluid flow in the distaldirection. Thus, when fluid is infused into connector 920 from a medicalimplement (e.g., a syringe), the annular cavity 988 expands until theforce required to further expand the annular cavity 988 is greater thanthe force required to open the regulator 930 for fluid flow in thedistal direction, at which point the regulator 930 opens and fluid ispushed out the distal end of the connector 920. When a syringe rebounds,or other backflow inducing event occurs, the body portion 900 of theregulator 930 can return to its unexpanded position, reducing the volumeof the annular cavity 988, compensating for the vacuum, and preventingbackflow from occurring. In some circumstances, the volume of theannular cavity 988 can be reduced beyond its natural, unexpanded volumeby the body portion 900 of the regulator 930 flexing inwardly into theannular cavity 988, thereby providing additional vacuum compensation. Insome embodiments, the body portion 900 of the regulator 930 can stretchas it expands so that the body portion 900 contains an amount ofpotential energy in its expanded state. In some embodiments, the amountof potential energy is not enough to produce adverse effects, such asraising the plunger of the syringe, or opening the slits in theregulator 930.

In some embodiments, the connector 920 can be configured so that thebody portion 900 of the valve body 930 is positioned substantially flushagainst the distal portion 964 of the support member 928 when in theunexpanded state. In this embodiment, no annular cavity 988 is presentwhen the body portion 900 is in the unexpanded state. The body portion900 can expand outwardly into the annular recess 923 when fluid isinfused into the connector 920. To prevent backflow, the body portion900 can return to the unexpanded state, but does not flex inwardly tofurther reduce the volume in the connector 920. In some embodiments, thedistal portion 964 of the support member 928 can be thicker than asshown in FIG. 50B, so that no annular cavity 988 is formed between theannular protrusions 990, 992, and the body portion 900 of the regulator930 can sit flush against the distal portion 996 of the support member928.

In some embodiments, the base member 924 can be formed without the hole929, and the annular recess 923 can be filled with a compressible fluid,such as air or some other gas. Thus, when the body portion 900 flexes,the compressible fluid can expand or compress, as needed, to allow thevolume of the annular recess 923 to increase or decrease accordingly.

FIG. 51 is a perspective view of an embodiment of a regulator 1030. Theregulator 1030 can be similar in some regards to the regulator 30, orany other regulator or valve member disclosed herein. In someembodiments, the regulator 1030 includes a body portion 1000, a proximalend portion 1002, and a distal end portion 1008. The proximal endportion 1002 can include an annular raised lip 1003 and an opening 1004therethrough. The distal end portion 1008 can be substantially domeshaped or hemispherically shaped, and can include a single slit 1010therethrough. The single slit 1010 can be formed to various differentsizes. In some embodiments, the width of the single slit 1010 can beequal to or smaller than the width of the opening 1004. The slit 1010can be symmetrically or asymmetrically formed in the distal end portion1008 of the regulator 1030.

FIG. 52 is a perspective view of an embodiment of a regulator 1130. Theregulator 1130 can be similar in some regards to the regulator 30, orany other regulator or valve member disclosed herein. In someembodiments, the regulator 1130 includes a body portion 1100, a proximalend portion 1102, and a distal end portion 1108. The proximal endportion 1102 can include an annular raised lip 1103 and an opening 1104therethrough. In some embodiments, the distal end portion 1108 can besubstantially dome shaped or substantially hemispherically shaped, andcan include a plurality of slits 1110 (e.g., five, as illustrated). Eachof the slits 1110 can meet at a center point on the distal end portion1108 of the regulator 1130 and extend radially outwardly along thedistal end portion 1108. In some embodiments a different numbers ofslits can be used, such as, but not limited to, three slits, six slits,seven slits, etc. The number of slits can be chosen depending on thedesired cracking pressure of the regulator 1130. Generally, a greaternumber of slits will result in a lower cracking pressure and theregulator 1130 will open more easily to allow fluid flow therethrough.

FIG. 53 is a perspective view of an embodiment of a regulator 1230. FIG.54 is a section view of the regulator 1230 taken along the axialcenterline of the regulator 1230 on a first plane. FIG. 55 is a sectionview of the regulator 1230 taken along the axial centerline of theregulator on a second plane that is orthogonal to the first plane. Theregulator 1230 can be similar in some regards to the regulator 30, orany other regulator or valve member disclosed herein. In someembodiments, the regulator 1230 includes a body portion 1200, a proximalend portion 1202, and a distal end portion 1208. The proximal endportion 1202 can include an annular raised lip 1203 and an opening 1204therethrough. In some embodiments, the distal end portion 1208 can besubstantially dome or hemispherically shaped, and can include a slit1210. In some embodiments, a cross beam 1209 (shown in phantom in FIG.53) is formed on either side of the slit 1209 with the slit 1209 passingtherethrough. The cross beam 1209 can function to increase the thicknessof the wall of the regulator across at least a portion of the width ofthe slit 1210, thereby increasing the cracking pressure required to openthe regulator 1230.

In some embodiments, the cross beam 1209 can be centered on the axialcenterline of the regulator 1230. With reference to FIG. 54, in someembodiments, the cross bar 1209 can have a width (represented by “WB” inFIG. 54) that is smaller than a width defined by the slit 1210(represented by “WS” in FIG. 54). In some embodiments, the width WB ofthe cross bar can extend across the full length of the width WS of theslit 1210, or beyond the width WS of the slit 1210. In some embodiments,multiple cross bars can be used to achieve a desired cracking pressurefor the regulator 1230.

FIG. 56 is a perspective view of a one-way valve member 1330. In someembodiments, the valve member 1330 can be substantially disk shaped andcan include a channel 1301 formed on one side thereof. The channel 1301can pass through the center of the valve member 1330. The valve member1330 can be constructed from a deformable, resilient material such assilicone-based deformable materials, rubbers, etc. The valve member 1330can be constructed from a material capable of forming a fluid tight sealagainst a plastic or other rigid material.

FIG. 57 is a section view of an embodiment of a valve or needlelessconnector 1320 configured to use the valve member 1330 shown in FIG. 56.In some embodiments, the connector 1320 can have any of the features orother details or configurations of any other connector described herein.In some embodiments, the connector 1320 can include a body member 1322,the base member 1324, a seal member 1326, a support member 1328, and aregulator 630, and the valve member 1330 which can be, for example, thesame as, or similar to, the body member 22, base member 24, seal member26, support member 28, and regulator 30 in connection with the connector20.

The base member 1324 can include a cavity 1329 therein, and a bar 1319can extend across at least a portion of the cavity 1329. The valvemember 1330 can be positioned on the bar 1319 so that the bar 1319 fitsinto the channel 1301 on the valve member 1330. The support member 1328can be positioned so that the distal surface of the annular protrusion1394 contacts the proximal surface of the valve member 1330. In someembodiments, the support member 1328 can force the valve member 1330 toflex slightly so that the resilient force of the valve member 1330 formsan annular seal against the distal surface of the annular protrusion1394.

FIG. 58 shows a section view of the connector 1320 shown in FIG. 57 withthe valve member 1330 in an open configuration while fluid is infusedthrough the connector 1320. Fluid can be infused into the connector 1320from a syringe 120 or other medical implement. The fluid can travelthrough a fluid passageway 1369 in the support member 1328 to the valvemember 1330. When the pressure in the fluid passageway 1369 issufficient greater than the pressure in the cavity 1321, the valvemember 1330 flexes away from the support member 1328, breaking the sealand allowing fluid to flow into the cavity 1321 and out of the connector1320 through the male tip protrusion 1341. When the pressure subsides(e.g., when fluid is no longer being infused), the valve member 1330resiliently returns to its closed position (as shown in FIG. 57),forming a seal against the support member 1328.

If a syringe rebound, or other backflow inducing event, occurs, thepressure differential can cause the valve member 1330 to press moretightly against the support member 1328, and backflow can be prevented.In some embodiments, the connector 1320 can include a regulator 630 (asdiscussed in connection with FIGS. 43-45). The regulator 630 can beconfigured to flex inwardly to reduce the volume of the annular cavity1388 to alleviate the pressure differential caused by the syringerebound or other backflow-inducing event. In some embodiments, the valvemember 1330 can be a check valve or one-way valve that substantiallyprevents fluid flow in the proximal direction. Therefore, in someembodiments, no regulator 630 providing a variable volume chamber isrequired to prevent backflow. However, in some embodiments, such as theembodiment shown in FIGS. 57 and 58, the regulator 630 can be includedso that the variable volume chamber can reduce in volume to alleviatethe pressure caused by a syringe rebound, or other backflow inducingevent.

Various other types of check valves can be used to prevent backflow. Forexample, FIG. 59 is a perspective view of a regulator 1430 that includesa generally flat, tapering closure valve such as a duckbill check valve1405. FIG. 60 is a section view of the regulator 1430 shown in FIG. 59.The regulator 1430 can be similar to the regulator 30, or to any otherregulator or valve member disclosed herein. In some embodiments, theregulator 1430 can include a body portion 1400, a proximal end portion1402, and a distal end portion 1408. The proximal end portion 1402 caninclude an annular raised lip 1403 and an opening 1404 therethrough. Thedistal end portion 1408 can include a duckbill check valve 1405 formedby two resilient generally flat, tapering surfaces or bills 1407 a, 1407b that meet to form an elongate slit 1410 extending in a generallytransverse direction across all or nearly all of the distal end thereof.The regulator 1430 can also include an inner annular protrusion 1412.Many variations are possible. For example, in some embodiments, thecheck valve 1405 and body portion 1400 of the regulator can be formedseparately.

FIG. 61 is a section view of a valve or needleless connector 1420 thatincludes the regulator 1430 in a closed configuration. FIG. 62 is asection view of the connector 1420 with the regulator 1430 in an openconfiguration as fluid is infused through the connector 1420. In someembodiments, the connector 1420 can have any of the features or otherdetails or configurations of any other connector described herein. Insome embodiments, the connector 1420 can include a body member 1422, abase member 1424, a seal member 1426, a support member 1428, and aregulator 1430 which can be, for example, the same as, or similar to,the body member 22, base member 24, seal member 26, support member 28,and regulator 30 of the connector 20. The regulator 1430 can bepositioned over the distal portion 1464 of the support member 1428,similarly to the regulator 30.

As fluid is infused into the connector 1420 from a medical implement(e.g., a syringe 120), the fluid can travel through the fluid passageway1469 to the duckbill check valve 1405. The pressure differential causedby the influx of fluid can cause the bills 1407 a, 1407 b on theduckbill check valve 1405 to separate, thereby opening the slit 1410 andallowing fluid to flow through the duckbill check valve 1405 and out theconnector 1420 through the male tip protrusion 1441.

If a syringe rebound, or other backflow inducing event, occurs, theresulting pressure differential can cause the bills 1407 a, 1407 b ofthe duckbill check valve 1405 to press against each other more tightly,preventing backflow of fluid. In some embodiments, the body portion 1400of the regulator 1430 can flex inwardly to reduce the volume in theconnector and alleviate some of the pressure caused by the syringerebound or other retrograde-inducing event. In some embodiments, theduckbill check valve 1405 can be configured to substantially preventflow of fluid in the distal direction. Accordingly, in some embodiments,the connector 1420 can include the duckbill check valve 1405, but canomit the body portion 1400 that provides the variable volume chamber.

In some embodiments, the backflow resist valve is not a check valve orone-way valve that substantially prevents backflow altogether. Rather,the backflow resist valve can prevent backflow until a certain thresholdpressure differential is reached, at which point the backflow resistvalve opens to allow backflow to occur. In some embodiments, thebackflow resist valve can be configured such that the threshold pressuredifferential is high enough to prevent unintentional backflow such asthat caused by syringe rebound or withdrawal of a medical implement, butlow enough to allow intentional backflow such as when fluid (e.g.,blood) is intended to be drawn through the connector into the syringe.In some embodiments, the regulator 30 can provide a two-way backflowresist valve, as discussed in greater detail elsewhere herein. Othertwo-way backflow resist valves can be used.

FIG. 63 is a perspective view of an embodiment of a regulator 1530 thatcan function to control fluid flow and/or mitigate the effects ofpressure differentials using a moving wall portion. In some embodiments,the moving wall portion can be generally flat and generally horizontalas illustrated. In some embodiments, the regulator 1530 can function asa two-way backflow resist valve, as will be described in more detailbelow. The regulator 1530 can include a resilient body portion 1500, aproximal moving wall or plug portion 1508, and a distal connectorportion 1502. The distal connector portion 1502 can include a hole 1504therethrough. The proximal wall or plug portion 1508 can besubstantially disk shaped, and can include an annular tapered or roundededge 1510 extending around the circumference of the plug portion 1508.In some embodiments, the wall or plug portion 1508 can be made of aresilient material, as illustrated, and in some embodiments, it can berigid or substantially rigid. The resilient body portion 1500 canconnect the plug portion 1508 to the connector portion 1502. In someembodiments, the resilient body portion 1500 can include one or moregenerally transverse or generally horizontal grooves, such as arecreated by a series of stacked o-rings, to assist in compression. Insome embodiments, the resilient body portion 1500 can include a springor other element that causes the resilient body portion 1500 to returnto its original state after being stretched or compressed. The regulator1530 can be constructed from a number of different suitable materials,including silicone-based deformable materials, rubbers, or othersuitable materials. In some embodiments, the regulator 1530, or portionsthereof, can be formed from a material that can form a fluid tight sealagainst a plastic or other rigid material.

FIG. 64 is a section view of a valve or needleless connector 1520 thatincludes the regulator 1530 in a relaxed position. In some embodiments,the connector 1520 can have any of the features or other details orconfigurations of any other connector described herein. In someembodiments, the connector 1520 can include a body member 1522, a basemember 1524, a seal member 1526, a support member 1528, the regulator630, and the regulator 1530 which can be, for example, the same as, orsimilar to, the body member 22, base member 24, seal member 26, supportmember 28, and regulator 30 of the connector 20.

In some embodiments, the base member 1524 includes a cavity 1521therein, and a support bar 1519 extends within or through the cavity1521. The connector portion 1502 can be configured to secure theregulator 1530 to the support bar 1519 with the support bar 1519extending through the opening 1504 in the connector portion 1502. Forexample, in some embodiments, the base member 1524 can be constructed oftwo pieces, split down the axial centerline of the base member 1524. Theregulator 1530 can be attached to one side piece of the base member 1524and then the two base member pieces can be coupled via a snap fit,plastic welding, sonic welding, etc., to form the base member 1524 withthe regulator 1530 secured thereto. The regulator 1530 can be secured tothe connector in various other manners. For example, in someembodiments, a portion of the regulator 1530 can be positioned betweentwo other components (e.g., the base member 1524 and the support member1528) of the connector 1520, providing a friction or pressure fit thatholds the regulator 1530 in place.

The cavity 1521 can include an annular ridge 1523 having a lower taperedsurface 1525 and an upper tapered surface 1527. In some embodiments, thesurface between the upper and lower tapered surfaces 1527, 1525 can besubstantially cylindrical. The plug portion 1508 of the regulator 1530can be seated against the annular ridge 1523 when the resilient bodyportion 1500 is in a relaxed or initial state. In some embodiments, theannular tapered edge of the plug portion 1508 is compressed slightly bythe annular ridge 1523 so as to form a generally fluid tight annularseal between the plug portion 1508 and the ridge 1523.

FIG. 65 is a section view of the connector 1520 in which the regulator1530 is in an open position as fluid is being infused through theconnector 1520 in the distal direction. As fluid is infused into theconnector 1520 from a medical implement (e.g., syringe 120), the fluidcan travel through the fluid passageway 1569 formed in the supportmember 1528 and into the upper portion of the cavity 1521 until thefluid contacts the top surface of the plug portion 1508 of the regulator1530. The pressure differential can cause the resilient body portion1500 to compress, lowering the plug portion 1508 until the plug portion1508 disengages from the annular ridge 1523, thereby breaking theannular seal and allowing the fluid to flow around the regulator 1530and out the male tip protrusion 1541 of the connector 1520. When thepressure subsides (e.g., when fluid is no longer being infused into theconnector 1520), the resilient body portion 1500 of the regulator 1530can return to its relaxed state (shown in FIG. 64) and reengage theannular seal between the plug portion 1508 and the annular ridge 1523.

FIG. 66 is a section view of the connector 1520 in which the regulator630 is in an open position as fluid is drawn through the connector 1520in the proximal direction. If a syringe rebound or otherbackflow-inducing event occurs, the resulting pressure differential cancause the regulator 630 to collapse (as shown in FIG. 66), therebyreducing the volume of the variable volume chamber and alleviating thepressure caused by the backflow-inducing event. In some embodiments, theregulator 1530 can be hollow or otherwise rendered sufficiently flexibleso that it can both provide a valving function and apressure-compensating function by changing its volume in response topressure changes. In some embodiments, the force required to collapsethe regulator 630 is less than the force required to stretch theresilient body member 1500 of the regulator 1530. Thus, the plug portion1508 of the regulator 1530 can remain substantially and substantiallynon-deforming as the regulator 630 collapses so that the fluid locateddistal of the plug portion 1508 is generally not influenced by thevacuum created by the backflow-inducing event thereby generally entirelypreventing fluid backflow.

In some embodiments, additional pressure can be applied after theregulator 630 has collapsed (e.g., by intentionally drawing back theplunger of the syringe 120). The additional pressure can cause theresilient body portion 1500 of the regulator 1530 to expand so that theplug portion 1508 slides axially up the annular ridge 1523. If enoughpressure is applied, the plug portion 1508 can disengage from theannular ridge 1523 and allow fluid to flow in the proximal directionthrough the connector 1520, as shown in FIG. 66. In some embodiments,the regulator 1530 can be configured so that the force required tostretch the resilient body portion 1500 far enough to open the regulator1530 for fluid flow in the proximal direction is greater than the forcerequired to compress the resilient body portion 1500 far enough to openthe regulator 1530 for fluid flow in the distal direction. In someembodiments, when the resilient body portion 1500 is in the relaxedstate, the plug portion 1508 is located closer to the lower taperedsurface 1525 than the upper tapered surface 1527.

In some embodiments, the thickness of the annular ridge 1523 (e.g., inthe vertical direction) can be substantially larger than in theillustrated embodiment, thereby allowing the plug portion or wall 1508to move a larger distance in either direction before opening the valveto fluid flow. For example, in some embodiments, the annular ridge 1523or other interfacing structure can be at least about twice or threetimes as thick as the plug portion or wall 1508 that moves along it. Theannular ridge 1523 or other interfacing structure can include a ledge,catch, or other impeding structure (not shown) to limit the movement ofthe wall or plug portion in the distal and/or proximal directions. Insome embodiments, this arrangement can create a one-way valve.

FIG. 67 is a perspective view of a regulator 1730. FIG. 68 is a sectionview of the regulator 1730 shown in FIG. 67 taken along the axialcenterline of the regulator 1730. With reference to FIGS. 67 and 68, theregulator 1730 can include a body portion 1700, a proximal end portion1702, and a distal end portion 1708. The proximal end portion caninclude an annular raised lip 1703 and an opening 1704 therethrough. Thedistal end portion 1708 can include a recessed central portion 1705 anda tapered annular wall 1706. One or more holes 1710 can be formedthrough the tapered annular wall. The regulator 1730 can also include aninner annular protrusion 1712. The regulator 1730 can be constructedfrom a number of different suitable materials, including silicone-baseddeformable materials, rubbers, or other suitable materials. In someembodiments, the regulator 1730, or portions thereof, can be formed froma material that can form a fluid tight seal against a plastic or otherrigid material.

FIG. 69 is a section view of a valve or needleless connector 1720 thatincludes the valve 1730 shown in FIGS. 67 and 68. The regulator 1730 isshown in an initial or relaxed (closed) state in FIG. 69. In someembodiments, the connector 1720 can have any of the features or otherdetails or configurations of any other connector described herein. Insome embodiments, the connector 1720 can include a body member 1722, abase member 1724, a seal member 1726, a support member 1728, and aregulator 1730 which can be, for example, the same as, or similar to,the body member 22, base member 24, seal member 26, support member 28,and regulator 30 of the connector 20.

The regulator 1730 can be positioned over the distal portion 1764 of thesupport member 1728, defining an annular cavity 1788 between two annularprotrusions 1790, 1792 on the support member 1728. The inner annularprotrusion 1712 of the regulator 1730 can be received within the channel1796 formed between the annular protrusions 1790, 1794 to secure theregulator 1730 to the support member 1728. In some embodiments, thedistal portion 1764 of the support member 1728 can be configured toreceive the distal end portion 1708 of the regulator 1730. The supportmember 1728 can include a tapered inner surface 1765 near the distalopening 1766 that is configured to receive the tapered annular wall 1706so as to form a fluid tight seal therebetween when the distal endportion 1708 of the regulator 1730 is in the relaxed position. When theregulator 1730 is in the relaxed position shown in FIG. 69, the holes1710 formed in the tapered annular wall 1706 can be covered by thetapered inner surface 1765 of the support member 1728 so that fluid doesnot flow through the holes 1765.

FIG. 70 is a partial section view of the connector 1720 in which theregulator 1730 is in an open position as fluid is being infused throughthe connector 1720 in the distal direction. As fluid is infused into theconnector 1720 from a medical implement (e.g., syringe), the fluid cantravel through the fluid passageway 1769 formed in the support member1728 until the fluid contacts the surface of the recessed center portion1705 of the regulator 1730. The pressure differential can cause thedistal end portion 1708 of the regulator 1730 to flex distally away fromthe support member 1728 until the tapered annular wall 1706 of theregulator 1730 disengages from the inner tapered wall 1765 of thesupport member 1728, thereby breaking the annular seal and allowing thefluid to flow through the holes 1710 in the regulator 1730 and out themale tip protrusion 1741 of the connector 1720. When the pressuresubsides (e.g., when fluid is no longer being infused into the connector1720), the resilient distal end portion 1708 of the regulator 1730 canreturn to its initial or relaxed state (shown in FIG. 69) so that thetapered annular wall 1706 reengages with, and seals against, the innertapered surface 1765 of the support member 1728.

FIG. 71 is a partial section view of the connector 1720 in which theregulator 1730 is in an open position as fluid is drawn through theconnector 1720 in the proximal direction. If a backflow-inducing eventoccurs, the resulting pressure differential can cause the body portion1700 of the regulator 1730 to collapse (as shown in FIG. 71), therebyreducing the volume of the annular cavity 1788 and alleviating thepressure caused by the syringe rebound or another backflow-inducingevent. In some embodiments, the force required to collapse the bodyportion 1700 of the regulator 1730 is less than the force required tostretch the annular tapered wall 1706 of the regulator 1730. Thus, therecessed central portion 1705 of the regulator 1730 can remainsubstantially unaffected as the body portion 1700 of the regulator 1730collapses or otherwise changes volume so that the fluid located distalof the regulator 1730 is generally not influenced by the vacuum createdby the syringe rebound or any other retrograde-inducing event, therebypreventing fluid backflow.

In some embodiments, additional pressure can be applied after the bodyportion 1700 of the regulator 1730 has collapsed (e.g., by intentionallydrawing back the plunger of the syringe). The additional pressuredifferential can cause the recessed central portion 1705 to be drawnproximally into the fluid passageway 1769 of the support member 1728 sothat the tapered annular wall 1706 stretches. If enough pressure isapplied, the holes 1710 formed in the tapered annular wall 1706 can beexposed, allowing fluid to flow in the proximal direction through theholes 1710 in the regulator 1730, as shown in FIG. 71. In someembodiments, the regulator 1730 can be configured so that the forcerequired to stretch the tapered annular wall 1706 far enough to exposethe holes 1710 and allow fluid flow in the proximal direction is greaterthan the force required disengage the tapered annular wall 1706 from theinner tapered wall 1765 of the support member 1728 to allow fluid flowin the distal direction.

FIG. 72 is a section view of a valve or needleless connector 1820. Insome embodiments, the connector 1820 can have any of the features orother details or configurations of any other connector described herein.In some embodiments, the connector 1820 can include a body member 1822,a base member 1824, a seal member 1826, a support member 1828, a valvemember 730, and a balloon member 1830, which can be, for example, thesame as, or similar to, the body member 22, base member 24, seal member26, support member 28, and regulator 30 of the connector 20.

In some embodiments, the distal portion 1864 of the support member 1828can include an internal cavity 1865 in fluid communication with thedistal opening 1866, the fluid passageway 1869, and the one or moreholes 1868 formed in the elongate portion 1862. In some embodiments, thesupport member 1828 can be formed without the one or more openingsformed laterally or radially through the distal portion. In someembodiments, the variable volume chamber can be contained within theinternal cavity 1865 of the support member 1865 rather than by anannular channel formed on the outside of the support member. In someembodiments, a variable volume chamber 1830, such as a balloon member1830, can be contained within the internal cavity 1865 of the supportmember 1828. The balloon member 1830 can be secured to the supportmember 1828 in many ways, such as by one or more tethers 1801, adhesive,etc. The variable volume chamber 1830 can have many different shapes andcan be positioned in many different places. In some embodiments, thevariable volume chamber 1830 is positioned in contact with or abuttingagainst one or more interior surfaces of the internal cavity 1865 (e.g.,in a corner thereof). The balloon member 1830 can be filled with acompressible/expandable fluid, such as air or other gas. The balloonmember 1830 can expand when the volume of fluid contained within theinternal cavity 1865 is reduced, thereby alleviating the pressuredifferential created by a backflow-inducing event.

In some embodiments, the valve member 730 can be positioned over thedistal end portion 1864 of the support member 1828 in a manner similarto that described in connection with FIG. 48. In some embodiments, theforce required to further expand the balloon member 1830 increases asthe balloon member 1830 expands. Therefore, if sufficient pressure isapplied (e.g., when intentionally drawing fluid into the syringe), atsome point the force required to further expand the balloon member 1830is greater than the force required to open the valve member 730 forfluid flow in the proximal direction. When this threshold pressure isreached, the one or more slits 710 on the valve member 730 open to allowfluid to flow through the valve member 730 in the proximal direction. Insome embodiments, the balloon member 1830 can be configured such thatits expanded volume at the threshold pressure is not large enough tointerfere with the flow of fluid (e.g., by sealing off either openinginto the cavity 1865, or by filling a portion of the cavity 1865). Insome embodiments, the one or more tethers 1801 can be configured tomaintain the balloon member 1830 at a position that does not interferewith fluid flow even when in the expanded state. In some embodiments,one or more retaining structures such as bars or walls (not shown) canprevent the balloon member 1830 from interfering with the flow of fluidwhen in the expanded state.

FIG. 73 is a perspective view of a support member 1928. FIG. 74 is asection view of a valve or needleless connector 1920 that includes thesupport member 1928. In some embodiments, the connector 1920 can haveany of the features or other details or configurations of any otherconnector described herein. In some embodiments, the connector 1920 caninclude a body member 1922, a base member 1924, a seal member 1926, thesupport member 1928, a regulator 1930 which can be, for example, thesame as, or similar to, the body member 22, base member 24, seal member26, support member 28, and regulator 30 of the connector 20.

In some embodiments, the distal portion 1964 of the support member 1928can comprise an internal cavity 1965 in fluid communication with thedistal opening 1966, the fluid passageway 1969, and the one or moreholes 1968 formed in the elongate portion 1962. The support member 1928can include one or more openings 1986 formed laterally or radiallythrough the distal portion 1964 thereof.

In some embodiments, the regulator 1930 can be positioned over thedistal portion 1964 of the support member 1928 in a manner similar tothat discussed in connection with the connector 20. In some embodiments,at least a portion of the body portion 1900 can be configured to stretchand expand, or otherwise move, through the opening 1968 formed in thedistal portion 1964 of the support member 1928 and into the internalcavity 1965. If a backflow-inducing event occurs, air from outside theconnector 1920 can pass through the hole 1929 and cause the body portion1900 of the regulator 1930 to expand into the internal cavity 1965,thereby reducing the volume of fluid in the internal cavity 1965 andalleviating the pressure differential caused by the syringe rebound,withdrawal of a medical implement, or other backflow-inducing event. Insome embodiments, the force required to cause the body portion 1900 toexpand into the internal cavity 1965 is less than the force required toopen the one or more slits 1910 on the regulator for fluid flow in theproximal direction. In some embodiments, if additional pressure isapplied, such as when intentionally drawing fluid from the connector1920 into a syringe, the slits 1910 on the regulator 1930 can open toallow fluid to flow in the proximal direction.

In some embodiments, the support member 1928 can include a protrusion1927 or other feature configured to be received by a notch (not shown)in the base member 1924 so as to align the opening 1986 in the distalportion 1964 of the support member 1928 with the hole 1929 in the basemember 1924. In some embodiments, the base member 1924 can include anannular air channel (not shown) in communication with the hole 1929 thatallows air to reach the area of the body portion 1900 of the regulator1930 that expands through the open 1986 even when the opening 1986 isnot aligned with the hole 1929. In some embodiments, the support member1928 can include multiple openings 1986 so that the body portion 1900 ofthe regulator 1930 can expand into the internal cavity 1965 frommultiple locations. The annular air channel can allow air to reach eachexpanding location from a single air hole 1929, or multiple air holes1929 can be formed in the base member 1924.

FIG. 75 is a section view of a support member 2028. FIG. 76 is a partialsection view of a portion of the support member 2028. With reference toFIGS. 75 and 76, in some embodiments, the distal portion 2064 of thesupport member 2028 can include an internal cavity 2065 in fluidcommunication with the distal opening 2066, the fluid passageway 2069,and the one or more holes 2068 formed in the elongate portion 2062. Thesupport member 2028 can include an opening 2086 formed laterally orradially through the distal portion 2064 thereof. In some embodiments,an inflatable member, such as bag member 2030 can be positioned in theopening 2086. The bag member 2030 can include a generally circularconnection region 2002 that forms an airtight seal with the walls of theopening 2086 in a seat formed therein so that air cannot move past theconnection region 2002 unless it enters the inner volume 2006 of the bag2030. The connection region 2002 can be secured to the walls of theopening 2086 on exterior and/or interior surface of the support member2028. The bag member 2030 can be folded, compressed, flattened, orotherwise made smaller in an initial position before fluid pressuredifferentials cause it to change its shape and volume.

FIG. 76 is a partial section view of the support member 2028 showing thebag member in a smaller-volume state. If a backflow-inducing eventoccurs, the bag member 2030 can inflate, expand, or otherwise move toincrease its effective volume within the internal cavity 2065 as theinner volume 2006 fills with air from outside. As the volume of theinner volume 2006 of the bag member 2030 increases, the remaining volumeof fluid in the internal cavity 2065 of the support member 2028decreases, thereby alleviating the pressure differential created by thebackflow event. In some embodiments, a backflow resist valve (e.g., thevalve member 730) can be coupled to the distal end of the support member2028 to cooperate with the variable volume chamber formed by the bagmember 2030 to prevent backflow in a manner similar to those discussedelsewhere herein.

In some, embodiments, the bag member 2030 can be constructed from aflaccid material (e.g., polyethylene) that can allow the bag member 2030to inflate without substantial (or, in some cases, without any)expansion or stretching, or the bag member 2030 can be constructed froman elastomeric material (e.g., rubber or silicone) that allows the bagmember 2030 to expand and contract. In some embodiments, the bag member2030 can be constructed from a material that is relativelynon-expandable, but is flexible enough to allow the bag member 2030 tounfold. In some embodiments, the bag member 2030 can be secured to theinside surface or outside surface of the support member 2028 rather thaninside the opening 2086 itself.

In some embodiments, the support member 2028 can include a protrusion orother feature (not shown) that is received by a notch in anothercomponent (e.g. a base member) to align the opening 2086 with an airhole. In some embodiments, an annular air channel can provide fluidcommunication between the opening 2086 and the air hole in a similarmanner to that discussed in connection with the connector 1920.

Many types of needleless connectors can include a backflow resistancemodule, such as any of those described herein. For example, FIG. 78 is aside view of a valve or needleless connector 2120, which can have somefeatures or characteristics similar in some regards to the 2452040xxSwabable Valve available from Halkey-Roberts Corporation of St.Petersburg, Fla. FIG. 79 is a section view of the connector 2120 shownin FIG. 78. Some features and characteristics of the connector 2120 aredescribed in U.S. Pat. No. 6,651,956, the entirety of which is herebyincorporated by reference herein for all that it discloses. In someembodiments, the connector 2120 can include a body member 2122, a basemember 2124, a seal member 2126, a support member 2128 and a regulator2130. In some embodiments, the support member 2128 can be formed withoutan elongate portion. The regulator 2130 and support member 2128, as wellas other components of the connector 2120, can provide a backflowresistance module that includes a variable volume chamber and/or abackflow resist valve. The backflow resistance module of the illustratedembodiment of the connector 2120 can operate in a manner similar to thatdescribed herein in connection with the connector 20 to preventbackflow. In some embodiments, the connector 2120 can include any otherbackflow resistance module, such as those that are similar to the otherbackflow resistant modules disclosed herein.

FIG. 80 is a side view of a valve or needleless connector 2220, whichcan have some features or characteristics similar in some regards to theSafeSite connector available from B. Braun Medical, Inc. FIG. 81 is asection view of the connector 2220. Some features and characteristics ofthe connector 2220 are described in U.S. Pat. No. 4,683,916, theentirety of which is hereby incorporated by reference herein for allthat it discloses. In some embodiments, the connector 2220 can include abody member 2222, a base member 2224, a disk valve 2225, an actuator2226 configured to open the disk valve 2225 when a medical implementattached to the connector 2220, a support member 2228, and a regulator2230. In some embodiments, the support member 2228 can be formed withoutan elongate portion. The regulator 2230 and support member 2228, as wellas other components of the connector 2220, can provide a backflowresistance module that includes a variable volume chamber and/or abackflow resist valve. The backflow resistance module of the illustratedembodiment of the connector 2220 can operate in a manner similar to thatdescribed herein in connection with the connector 20 to preventbackflow. In some embodiments, the connector 2220 can include any otherbackflow resistance module, such as those that are similar to the otherbackflow resistance modules disclosed herein.

Although the connector disk valve 2225 can be configured to seal theconnector against fluid flow in the proximal direction as the medicalimplement is removed from the connector 2220, a small amount of backflowcan occur as the medical implement is withdrawn before the disk valve2225 closes. Also, some sources of backflow, such as syringe rebound,can occur while the connector 2220 is attached to a medical implementand the disk valve 2225 is open. The backflow resistance module of theconnector 2220 can be configured to eliminate or reduce the effects ofthese backflow inducing events.

FIG. 82 is a side view of a valve or needleless connector 2320, whichcan have some features or characteristics similar in some regards to theMaxPlus connector available from Medegen, Inc. of Ontario, Calif. FIG.83 is a section view of the connector 2320. Some features andcharacteristics of the connector 2320 are described in U.S. Pat. No.5,782,816 and U.S. Patent Publication No. 2005/0059952, the entiretiesof each of which are both hereby incorporated by reference herein forall that they disclose. In some embodiments, the connector 2320 caninclude a body member 2322, a base member 2324, a resilient plug seal2326, a support member 2328, and a regulator 2330. The regulator 2330and support member 2328, as well as other components of the connector2320, can provide a backflow resistance module that includes a variablevolume chamber and a backflow resist valve. The backflow resistancemodule of the illustrated embodiment of the connector 2320 can operatein a manner similar to that described herein in connection with theconnector 20 to prevent backflow. In some embodiments, the connector2320 can include any other backflow resistance module, such as thosethat are similar to the other backflow resistance modules disclosedherein.

In some embodiments, the connector 2320 can be configured to produce apositive flow of fluid in the distal direction as a medical implement isdisconnected from the connector 2320. For example, as a medicalimplement is connected to the connector 2320, the resilient plug seal2326 can collapse and increase the volume of fluid inside the connector2320. Then, as the medical implement is later removed, the resilientplug seal 2326 can expand reducing the volume of fluid in the connector2320 and alleviating the pressure caused by removal of the medicalimplement. However, some sources of backflow, such as syringe rebound,can occur while the connector 2320 is attached to the medical implementand the resilient plug member 2326 is maintained in the compressedstate. The backflow resistance module of the connector 2320 can beconfigured to eliminate or reduce the effects of the backflow inducingevents not resolved by the resilient plug seal 2326. In someembodiments, the variable volume chamber formed at least in part by theregulator 2330 can change in volume independent of movement of theresilient plug seal 2326. In some embodiments, as a medical implement isattached to the connector, the variable volume chamber formed at leastin part by the regulator 2330 can reduce in volume as fluid flows intothe increasing volume around the resilient plug seal 2326, preventing orresisting backflow of fluid that would otherwise be drawn into thedistal end of the connector 2320 (e.g., from a catheter). The variablevolume chamber formed at least in part by the regulator 2330 canincrease in volume as fluid is infused through the connector 2320 in thedistal direction so that the backflow resistance module can be preparedto handle later backflow inducing events.

FIG. 84 is a side view of a valve or needleless connector 2420, whichcan have some features or characteristics similar in some regards to theCLEARLINK connector available from Baxter International, Inc., ofDeerfield, Ill. FIG. 85 is a section view of the connector 2420. Somefeatures and characteristics of the connector 2420 are described in U.S.Pat. No. 6,585,229, the entirety of which is hereby incorporated byreference herein for all that it discloses. In some embodiments, theconnector 2420 can include a body member 2422, a base member 2424, aseal member 2426, a plug member 2425 slidably received inside the sealmember 2426, a support member 2428, and a regulator 2430. The regulator2430 and support member 2428, as well as other components of theconnector 2420, can provide a backflow resistance module that includes avariable volume chamber and/or a backflow resist valve. The backflowresistance module of the illustrated embodiment of the connector 2420can operate in a manner similar to that described herein in connectionwith the connector 20 to prevent backflow. In some embodiments, theconnector 2420 can include any other backflow resistance module, such asthose that are similar to the other backflow resistance modulesdisclosed herein.

FIG. 86A is a side view of a valve or needleless connector 2520, whichcan have some features or characteristics similar in some regards to theSmartSite connector available from Cardinal Health, Inc. of Dublin,Ohio. FIG. 86B is a section view of the connector 2520. Some featuresand characteristics of the connector 2520 are described in U.S. Pat. No.5,676,346, the entirety of which is hereby incorporated by referenceherein for all that it discloses. In some embodiments, the connector2520 can include a body member 2522, a base member 2524, a seal member2526, a support member 2528, and a regulator 2530. In some embodiments,the support member 2528 does not include an elongate portion but insteadincludes a proximally extending projection 2562 that can besubstantially shorter and does not extend through the proximal end ofthe seal member 2526. The regulator 2530 and support member 2528, aswell as other components of the connector 2520, can provide a backflowresistance module that includes a variable volume chamber and/or abackflow resist valve. The backflow resistance module of the illustratedembodiment of the connector 2520 can operate in a manner similar to thatdescribed herein in connection with the connector 20 to preventbackflow. In some embodiments, the connector 2520 can include any otherbackflow resistance module, such as those that are similar to the otherbackflow resistance modules disclosed herein.

FIG. 87A is a side view of a valve or needleless connector 2620, whichcan have some features or characteristics similar in some regards to theUltraSite connector available from B. Braun Medical, Inc. FIG. 87B is asection view of the connector 2620. Some features and characteristics ofthe connector 2620 are described in U.S. Pat. No. 5,439,451, theentirety of which is hereby incorporated by reference herein for allthat it discloses. In some embodiments, the connector 2620 can include abody member 2622, a base member 2624, a plug member 2625, a resilientseal member 2626, a support member 2628, and a regulator 2630. Theregulator 2630 and support member 2628, as well as other components ofthe connector 2620, can provide a backflow resistance module thatincludes a variable volume chamber and a backflow resist valve. Thebackflow resistance module of the illustrated embodiment of theconnector 2620 can operate in a manner similar to that described hereinin connection with the connector 20 to prevent backflow. In someembodiments, the connector 2620 can include any other backflowresistance module, such as those that are similar to the other backflowresistance modules disclosed herein.

FIG. 88A is a side view of a valve or needleless connector 2720, whichcan have some features or characteristics similar in some regards to theQ-Syte connector available from Becton, Dickinson and Company, ofFranklin Lakes, N.J. FIG. 88B is a section view of the connector 2720.Some features and characteristics of the connector 2720 are described inU.S. Pat. No. 6,908,459, the entirety of which is hereby incorporated byreference herein for all that it discloses. In some embodiments, theconnector 2720 can include a body member 2722, a base member 2724, aseal member 2726, a support member 2728, and a regulator 2730. Theregulator 2730 and support member 2728, as well as other components ofthe connector 2720, can provide a backflow resistance module thatincludes a variable volume chamber and/or a backflow resist valve. Thebackflow resistance module of the illustrated embodiment of theconnector 2720 can operate in a manner similar to that described hereinin connection with the connector 20 to prevent backflow. In someembodiments, the connector 2720 can include any other backflowresistance module, such as those that are similar to the other backflowresistance modules disclosed herein.

FIG. 89A is a side view of a valve or needleless connector 2820, whichcan have some features or characteristics similar in some regards to thePosiflow connector available from Becton, Dickinson and Company, ofFranklin Lakes, N.J. FIG. 89B is a section view of the connector 2820.Some features and characteristics of the connector 2820 are described inU.S. Pat. No. 6,152,900, the entirety of which is hereby incorporated byreference herein for all that it discloses. In some embodiments, theconnector 2820 can include a body member 2822, a base member 2824, aseal member 2826, a resilient member 2825, a support member 2828, and aregulator 2830. The regulator 2830 and support member 2828, as well asother components of the connector 2820, can provide a backflowresistance module that includes a variable volume chamber and/or abackflow resist valve. The backflow resistance module of the illustratedembodiment of the connector 2820 can operate in a manner similar to thatdescribed herein in connection with the connector 20 to preventbackflow. In some embodiments, the connector 2820 can include any otherbackflow resistance module, such as those that are similar to the otherbackflow resistance modules disclosed herein.

In some embodiments, the connector 2820 can be configured to produce apositive flow of fluid in the distal direction as a medical implement isdisconnected from the connector 2820 to alleviate the pressure caused byremoval of the medical implement. However, some sources of backflow,such as syringe rebound, can occur while the connector 2820 is attachedto the medical implement. The backflow resistance module of theconnector 2820 can be configured to eliminate or reduce the effects ofthe backflow inducing events not otherwise resolved. In someembodiments, the variable volume chamber formed at least in part by theregulator 2830 can change in volume independent of movement of the sealmember 2826 and resilient member 2825 caused by attachment or removal ofa medical implement. In some embodiments, as a medical implement isattached to the connector 2820, the variable volume chamber formed atleast in part by the regulator 2830 can reduce in volume as fluid flowsinto the increasing volume in the seal member 2826, preventing backflowof fluid that would otherwise be drawn into the distal end of theconnector 2820 (e.g., from a catheter). The variable volume chamberformed at least in part by the regulator 2830 can increase in volume asfluid is infused through the connector 2820 in the distal direction sothat the backflow resistance module can be prepared to handle laterbackflow inducing events.

FIG. 90A is a side view of a valve or needleless connector 2920, whichcan have some features or characteristics similar in some regards to theCLC2000 connector available from ICU Medical, Inc., of San Clemente,Calif. FIG. 90B is a section view of the connector 2920. Some featuresand characteristics of the connector 2920 are described in U.S. Pat. No.6,245,048, the entirety of which is hereby incorporated by referenceherein for all that it discloses. In some embodiments, the connector2920 can include a body member 2922, a base member 2924, a piston 2926slidably positioned in the body member 2922, a support member 2928, anda regulator 2930. The regulator 2930 and support member 2928, as well asother components of the connector 2920, can provide a backflowresistance module that includes a variable volume chamber and a backflowresist valve. The backflow resistance module of the illustratedembodiment of the connector 2920 can operate in a manner similar to thatdescribed herein in connection with the connector 20 to preventbackflow. In some embodiments, the connector 2920 can include any otherbackflow resistance module, such as those that are similar to the otherbackflow resistance modules disclosed herein.

In some embodiments, the connector 2920 can be configured to produce apositive flow of fluid in the distal direction as a medical implement isdisconnected from the connector 2920. The piston 1926 can be configuredto slide down the body portion 1922 of the connector 2920 as the medicalimplement is attached, so that the volume of fluid around the plug 1926increases. Then, as the medical implement is detached, the piston 2926can slide up the body portion 1922, reducing the volume of fluid aroundthe piston 2926 and alleviating the pressure caused by removal of themedical implement. However, some sources of backflow, such as syringerebound, can occur while the connector 2920 is attached to the medicalimplement. The backflow resistance module of the connector 2920 can beconfigured to eliminate or reduce the effects of the backflow inducingevents not resolved by the piston 2926. In some embodiments, thevariable volume chamber formed at least in part by the regulator 2930can change in volume independent of movement of the piston 2926 causedby attachment or removal of a medical implement. In some embodiments, asa medical implement is attached to the connector 2920, the variablevolume chamber formed at least in part by the regulator 2930 can reducein volume as fluid flows into the increasing volume around the piston2926, preventing backflow of fluid that would otherwise be drawn intothe distal end of the connector 2920 (e.g., from a catheter). Thevariable volume chamber formed at least in part by the regulator 2930can increase in volume as fluid is infused through the connector 2920 inthe distal direction so that the backflow resistance module can beprepared to handle later backflow inducing events.

FIG. 91A is a side view of a valve or needleless connector 3020, whichcan have some features or characteristics similar in some regards to theInVision-Plus connector available from RyMed Technologies, Inc., ofFranklin, Tenn. FIG. 91B is a section view of the connector 3020. Somefeatures and characteristics of the connector 3020 are described in U.S.Pat. No. 6,994,315, the entirety of which is hereby incorporated byreference herein for all that it discloses. In some embodiments, theconnector 3020 can include a body member 3022, a base member 3024, aseal member 3026, a guide member 3025, a septum member 3027, a supportmember 3028, and a regulator 3030. The regulator 3030 and support member3028, as well as other components of the connector 3020, can provide abackflow resistance module that includes a variable volume chamberand/or a backflow resist valve. The backflow resistance module of theillustrated embodiment of the connector 3020 can operate in a mannersimilar to that described herein in connection with the connector 20 toprevent backflow. In some embodiments, the connector 3020 can includeany other backflow resistance module, such as those that are similar tothe other backflow resistance modules disclosed herein.

In some embodiments, the seal member 3026 can include a series ofo-rings, arcuate segments, or other structures that facilitate theresilient return of the valve member 3026 to the uncompressed positionafter being compressed. In some embodiments, the o-rings, arcuatesegments, or other structures can be joined end-to-end to generally forma helical pattern down the body of the seal member 3026, as shown, forexample in FIG. 91B.

Although the embodiments shown in FIGS. 78-91B are illustrated as havinga backflow resistance module provided by a support member and aregulator similar in some regards to the support member 28 and regulator30, it will be understood that any other backflow resistance modules canbe incorporated into the connectors shown in FIGS. 81A-91B, includingthose described herein.

Although some specific examples have been provided herein, it should beunderstood that a backflow resistance module can be incorporated intomany other types of connectors than those specifically disclosed herein.For example, a backflow resistance module can be incorporated into ay-site connector, or into a connector providing access to an IV bag orother medication container, or into a catheter line.

Any features of the embodiments shown and/or described in the figuresthat have not been expressly described in this text, such as distances,proportions of components, etc. are also intended to form part of thisdisclosure. Additionally, although these inventions have been disclosedin the context of various embodiments, features, aspects, and examples,it will be understood by those skilled in the art that the presentinventions extend beyond the specifically disclosed embodiments to otheralternative embodiments and/or uses of the inventions and obviousmodifications and equivalents thereof. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combined with, or substituted for, one another inorder to perform varying modes of the disclosed inventions. Thus, it isintended that the scope of the present inventions disclosed hereinshould not be limited by the particular disclosed embodiments describedherein.

Although this invention has been disclosed in the context of a certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or subcombinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can be combinewith or substituted for one another in order to form varying modes ofthe disclosed invention. Thus, it is intended that the scope of thepresent invention herein disclosed should not be limited by theparticular disclosed embodiments described above.

The following is claimed:
 1. A medical connector that is resistant toretrograde fluid flow comprising: a base member comprising a male tipprotrusion extending in a distal direction, the male tip protrusioncomprising an internal proximal opening, a distal opening, and apassageway extending between the proximal and distal openings; aproximal body member affixed to the base member in a permanent manner,the proximal body member including a proximal end opening; a proximalseal member with a first position and a second position, the proximalseal member comprising a proximal end surface and a distal end, theproximal end surface being generally even with the proximal end openingof the body member in the first position and being displaced distallyfrom the proximal end opening of the body member in the second position,and the proximal seal member comprising an interior passage with aproximal end and a distal end; a support member formed separately fromand not unitary with the male tip protrusion of the base member, thesupport member being positioned within the medical connector in a fixedposition with respect to the base member, the support member comprisinga distal base portion located between a portion of the base member and aportion of the proximal body member, and the support member comprisingan elongate portion with a proximal end and a distal end, the proximalend of the elongate portion being positioned within the proximal sealmember, in a proximal region of the interior passage in the firstposition, the support member further comprising one or more fluidopenings and an internal fluid passageway; and a dome valve positionedin a region inside of the medical connector between the distal baseportion of the support member and the internal proximal opening of themale tip protrusion, the distance from the distal end of the proximalseal member to a proximal end of the dome valve being less than thedistance from the internal proximal opening of the male tip protrusionto the distal opening of the male tip protrusion; wherein the dome valveis configured to open to permit fluid to flow from a proximal side ofthe dome valve to a distal side of the dome valve under a first fluidpressure differential between a proximal region of the medical connectorand a distal region of the medical connector, and the dome valve isconfigured to open to permit fluid flow from the distal side of the domevalve to the proximal side of the dome valve under a second fluidpressure differential between a distal region of the medical connectorand the proximal region of the medical connector that is higher than thefirst fluid pressure differential, and wherein opening of the dome valveis not functionally dependent on opening of the proximal seal member. 2.The medical connector of claim 1, wherein the elongate portion of thesupport member penetrates through the proximal end surface of theproximal seal member in the second position of the proximal seal member.3. The medical connector of claim 1, wherein the elongate portion of thesupport member does not penetrate through the proximal end surface ofthe proximal seal member in the second position of the proximal sealmember.
 4. The medical connector of claim 1, wherein the elongateportion is tapered.
 5. The medical connector of claim 4, wherein aproximal tip of the elongate portion is tapered.
 6. The medicalconnector of claim 1, wherein the medical connector further comprises adynamic regulator.
 7. The medical connector of claim 1, wherein themedical connector does not comprise a dynamic regulator.
 8. The medicalconnector of claim 1, wherein the permanent attachment between theproximal body member and the distal base member is performed usingadhesive, plastic or sonic welds, snap, interference, or press-fitfeatures.
 9. The medical connector of claim 1, wherein the proximalopening of the proximal body of the medical connector is configured toreceive a luer of a medical implement.
 10. The medical connector ofclaim 9, wherein the male tip protrusion of the base member of themedical connector is a luer.
 11. The medical connector of claim 1,wherein a portion of the support member extends into an interior regionof the dome valve.
 12. The medical connector of claim 1, wherein the oneor more fluid openings in the support member is or are located in theelongate portion of the support member.
 13. The medical connector ofclaim 12, wherein the one or more fluid openings in the elongate portionof the support member is or are located on a lateral side of theelongate portion.
 14. The medical connector of claim 12, wherein the oneor more fluid opening in the elongate portion of the support member isor are located on a proximal end of the elongate portion.
 15. Themedical connector of claim 1, wherein the dome valve has a dome shapewhen the proximal seal member is in both the open and the closedpositions.
 16. The medical connector of claim 1, wherein the dome valveis biased toward a closed position when the proximal seal member is inboth the open position and the closed position.
 17. The medicalconnector of claim 16, wherein the dome valve opens only during fluidflow.
 18. The medical connector of claim 1, wherein the connector isconfigured to prevent retrograde flow of fluid in response to one ormore external fluid disturbances.
 19. The medical connector of claim 18,wherein the one or more external fluid disturbances is a patient's coughor an increase in a patient's blood pressure.
 20. The medical connectorof claim 18, wherein the one or more external fluid disturbances includesyringe plunger rebound.
 21. The medical connector of claim 18, whereinthe one or more external fluid disturbances include connection ordisconnection of the medical connector.
 22. The medical connector ofclaim 1, wherein the fluid flow extends in a generally straight paththrough the connector.